list of registered drugs for january – december 2013
TRANSCRIPT
DRUGS REGISTERED IN JANUARY 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT
CLASSIFICATION STATUS
37) 14.01.13
Health 2000 Enalapril 10mg Tablets
Enalapril maleate USP 10mg
S Kant Healthcare Limited, India
Health Brands Limited
Antihypertensive List 4
38) 14.01.13
X’tor 10 film coated tablets
Atorvastatin 10mg Ipca Laboratories Limited, India
Servi-Care Distributors Limited
Antihyperlipidemic agent
List 4
39) 18.01.13
Cloprez 75mg Film-Coated Tablets
Clopidogrel 75 mg MSN Laboratories Limited, Andhra Pradesh, India
Medical Products Limited
Antiplatelet Agent List 4
40) 18.01.13
Xiomida 300mg Film Coated Tablets
Oxcarbazepine 300mg
Jubilant Life Sciences Limited, Uttarakhand, India
Medical Products Limited
Anticonvulsants List 4
41) 18.01.13
Glemont-CT4 Chewable Tablets
Montelukast Sodium equivalent to Montelukast 4mg)
Glenmark Pharmaceuticals Limited, India
T. Geddes Grant Distributors Ltd
Leukotriene modifiers
List 4
42) 18.01.13
Valsaden 320mg/25mg Film Coated Tablets
Valsartan 320mg & Hydrochlorothiazide 25mg
Krka dd Novo Mestro, Slovenia
Servi-Care Distributors Ltd
Antihypertensive List 4
43) 31.01.13
Valsacor 320mg Film Coated Tablets
Valsartan 320mg Krka dd Novo Mestro, Slovenia
Servi-Care Distributors Ltd
Antihypertensive List 4
44) 31.01.1 Valsacor Valsartan 160mg Krka dd Novo Servi-Care Antihypertensive List 4
3 160mg Film Coated Tablets
Mestro, Slovenia Distributors Ltd
14.01.13
Boostrix suspension for injection in prefilled Syringe-preservative free monodose
Each dose (0.5ml) contains:Diphtheria toxoid not less than 2IU, Tetanu toxoid not less than 20IU, Prtussis toxoid 8mcg, Filamentous haemagglutinin 8mcg, Pertactin 2.5mcg, Adsorbed on aluminium hydroxide (ALCOH3) 0.3mg A13+, and aluminum phosphate (ALPO4) 0.2MG A13+
GlaxoSmithKline Biologicals S.A., Belgium
GlaxoSmithKline Caribbean Limited
Toxoid List 4
45) 31.01.13
Valsacor 80mg Film Coated Tablets
Valsartan 80mg Krka dd Novo Mestro, Slovenia
Servi-Care Distributors Ltd
Antihypertensive List 4
DRUGS REGISTERED IN JANUARY 2013DATE PRODUCT GENERIC
DESIGNATIONMANUFACTURER LOCAL AGENT CLASSIFICATIO
NSTATUS
1)
28.01.13
Prostatin Premium Male Formula Capsules
Each capsule contains vitamin B12 3mcg, Zinc 7.5mg, selenium 50mcg, proprietary blend 250mg
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamins & Minerals
List 2
2)
28.01.13
Vision Support Capsules
- Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamins & Herbs List 2
3)
28.01.13
Sleep Nice Capsules Passion flower 100mg, chamomile flowers 100mg St. john’s wort herb 60mg
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
4)
28.01.13
Osteo X-1 tablets Each tablet contains 100mg ipriflavone, VitaminD3 equivalent to 133.33IU Vitamin D
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamins List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION
STATUS
5) 05.02.13
Vitabiotics PregnaCare His and Her Conception-Wellman Conception Tablets
Each tablet contains:Vitamin A, as Dry Vitamin A Acetate type 250CWS/A 750ug, Vitamin D3 100 CWS/AM {100,00iu/g} 15ug, Vitamin C as L-Ascorbic acid DC 97% gran starch free 90mg, Thiamin (vitamin B1) as Thiamin Mononitrate DC 97% 12mg, Vitamin B6 as Pyridoxine Hydrochloride 97% 19mg, Riboflavin (vitamin B2) as Riboflavin 5mg, Vitamin B12 as Cyanocobalamin {vitamin B12} Crystalline 75ug, Biotin as D-Biotin 150ug, Folacin as Folic Acid 400mg, Niacin {Vitamin B3} as Nicotinamide 18mg, Pantothenic as Calcium D-Pantothenate 10mg, Vitamin E as Alpha Tocopheryl Acid Succinate 30mg, L-Arginine as L-Arginine Mono Hydrochloride 10mg, Iron as Ferrous Fumanate 6mg, Magnesium as Magnesium Oxide 60mg, Zinc as Zinc Sulphate Monohydrate 15mg, Manganese as Manganese Sulphate Monohydrate 0.50mg, Copper
Thompson & Copper Ltd, Cheshire United Kingdom
Cari-Med Limited Vitamins & Minerals
List 2
as Copper Sulphate Dried 1mg, Chromium as Chromium Trichloride 6H20 50ug, Selenium as Sodium Selenate Anhydrous 150ug, Siberian Ginseng Extract as Siberian Ginseng Extract 4:1 30mg, CoQ10 as Co-Enzyme Q10 2mg, L-Carnitine Tartrate as L-Carnitine Tartrate 50mg, Citrus Bioflavonoids 60% as Citrus Bioflavonoids 60% 10mg, L-Glutathione as L-Glutathione 2.50mg, Maca as Maca Extract 250mg, Pine Bark Extract as Pine Bark Extract 95% Proanthocyanidins 30mg, Octacosanol as Rice Bran 3mg, Inositol as Inositol 40mg, Lycopene Extract 5% as Lycopene (Standardized Extract 5%) 1.5mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT
CLASSIFICATION
STATUS
6)
05.02.13
Vitabiotics Wellteen Plus Omega 3-Wellteen Tablets
Each tablet contains:Vitamin A as VitaminA acetate (dry type325) 400ug, Natural Mixed Cartenoids as carocare nat. betacarotene 20% V 2mg, Thiamin {vitamin B1} as thiamin mononitrate DC 97% 6mg, Riboflavin (vitamin B2) as Riboflavin 3mg, Vitamin D3 as vitamin D3 100 CWS/AM {100,00IU/g}20ug, Folacin (Flolic Acid) as folic acid 400ug, Vitamin B12 as Cyanocobalamin {vitamin B12} crystalline 15ug, Vitamin B6 as pyridoxine hydrochloride 97% 8mg, Patothenic Acid as Calcium D-Pantothenate 6mg, Biotin as D-Biotin 75ug, Vitamin C as Ascorbic Acid {vitamin C} DC 97% 80mg, Vitamin E as D Alpha Tocopheryl Acid Succinate 8mg, Niacin {vitamin B3} as Nicotinamide 18mg, Zinc as Zinc Sulphate Monohydrate 15mg, Iron as Ferrous Fumarate 12mg, Selenium as Sodium Selenate Decahydrate 55ug, Magnesium as Magnesium Oxide, granulated USP 94mg, Manganese as Manganese Sulphate Monohydrate
Thompson & Copper Ltd, Cheshire United Kingdom
Cari-Med Limited
Vitamins & Herbs List 2
2mg, Copper as Copper Sulphate Dried 1mg, Iodine as Potassium Iodide 130ug, Chromium as Chromium Trichloride 6H20 50ug, L-Carnitine Tartate as L-Carnitine Tartrate 50mg, Green Tea Extract {equivalent {as Green Tea Extract 8:1 40mg, Cranberry {as Cranberry Extract 15:1 CRA-STD 100mg, CoQ10 {as Co-Enzyme Q10 2mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT
GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT
CLASSIFICATION STATUS
7)
05.02.13
Vitabiotics Osteocare Tablets
Each tablet contains: Calcium {as magnesium hydroxide) 800mg, magnesium {as magnesium hydroxide) 150mg, zinc (as zinc sulphate monohydrate} 5mg, vitamin D {as vitamin D3 (500IU/mg) EC) 5mcg
Thompson & Copper Ltd, Cheshire United Kingdom
Cari-Med Limited
Minerals List 2
8)
05.02.13
Health 2000 Diclofenac Gel B.P.
Each gel contains:Diclofenac diethylamine B.P., 1.16% w/v (equivalent to diclofenac sodium B.P. 1% w/w) in a gel base
M/S Tuton Pharmaceuticals, Gujarat, India
Health Brands Ltd
Analgesic List 2
9)
06.02.13
Pectylin-C Expectorant
Each tablet contains:Diphenhydramine hydrochloride B.P., 14mg, Ammonium Chloride B.P., 135mg, Sodium Citrate P.p., 1.1mg.
Ipca Laboratories Ltd, Sejavta, India
Servi-Care Distributors Ltd,
Antihistamine, Expectorant
List 2
10) 06.02.13
Clean and Clear Advantage 3-in-1 Foaming Acne Wash
Contains: Salicylic Acid 2% Vee Pak Inc., Illinois, USA
Cari-Med Limited
Keratolytic,bacteriocidal & comedolitic agent
List 2
DRUGS REGISTERED IN FEBRUARY 2013
DPRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
0Neutrogena
Contains: Sa
Neutrogena Co
Kirk Distri
Keratolytic,bacterioc
List 2
Oil-Free Acne Stress Control Powe
licylic Acid 2%
rporation, California, USA
butors Limited
idal & comedolitic agent
r-Cream0Vitabiotics PregnaCa
Each tablet contains:N
Thompson & Copper Ltd, C
Cari-Med Limited
Vitamins & Minerals
List 2
re His and Her Conception-Pregnac
atural Mixed Carotenoids as Carocare N
heshire United Kingdom
are Conception Tablets
at. Betacarotene 20% V 36mg, Thiamin
(vitamin B1) as Thiamin Mononitrate 8mg,
Riboflavin (vitamin B2) as Riboflavin 5mg
, Vitamin D3 as Vitamin D3 100 CWS/AM {100
,000 IU/g} 15ug, Folacin as (Folic Acid)
as Folic Acid 400ug, Vitamin B12 as Vitamin
B12 0.1% WS {Cyanocobalamin Prep.} 20
ug, Vitamin B6 as Pyridoxine Hydrochlor
ide 10mg, Pyridoxine Hydrochloride as
Calcium D-Pantothenate 6mg, Biotin as
D-Biotin 150ug, Vitamin C as Coated Asco
rbic Acid Type FC 90mg, Vitamin E as D Al
pha Tocopheryl Acid Succinate 30mg, Ni
acin {Vitamin B3} as Nicotinamide 20mg, Z
inc as Zinc Sulphate Monohydrate 15mg,
Iron as Ferrous Fumarate 14mg, Seleniu
m as Sodium Selenate Anhydrous 50ug,
Magnesium as Magnesium Oxide Granul
ated USP 60mg, Copper as Copper Sulphat
e Dried 1mg, Iodine as Potassium Iodid
e 140ug, Inositol as Inositol 50mg, L-Arg
inine as L-Arginine Mono Hydrochlorid
e {Veggie} 100mg, N-Acetyl Cysteine as
N-Acetyl Cysteine IP 50mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION
STATUS
13) 05.02.13
Lergi Tablets Cetirizine Hydrochloride B.P. Tablets 10mg
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Antihistamine List 2
14) 27.02.13
CO Q-10 30mg Softgels
Coenzyme Q10 Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamins List 2
15) 27.02.13
Aurovite-M Syrup
Vitamin A Palmitate BP 3000IU, Vitamin D³ BP 500IU, Vitamin B¹ BP 2mg, Riboflavin Sodium Phosphate BP 1.2mg, Nicotinamide BP 10mg, Vitamin B¹² BP 2.5mcg, Vitamin C BP 40mg, Vitamin B6 BP 1mg, Flavoured Syrup Base q.s., per 5ml
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Vitamins List 2
16) 27.02.13
Vitamin C 1000mg Tablets
Vitamin C 1000mg (Ascorbic acid)
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Vitamins List 2
17) 27.02.13
Ultra B Complex Tablets
Vitamin B¹ 100mg, Vitamin B² 100mg, Vitamin B³ 100mg, Vitamin B6 100mg, Folic Acid 800mcg, Vitamin B¹² 100mcg, Biotin 500mcg, Vitamin B5 100mg.
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamins List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT
CLASSIFICATION STATUS
18) 27.02.13
Triple Alflexil Triple Strength Tablets
Two tablets contain: Glucosamine HCI 1500mg,Chondroitin Complex 800mg, MSM 750mg)
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
19) 27.02.13
Ginkgo Biloba Capsules
Ginkgo biloba leaves powder 300mg,Ginkgo biloba leaves extract 60mg, 24%/6% standardized
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
20) 27.02.13
Ginseng with Ginkgo Biloba Tablets
Ginseng root 150mg, ginkgo biloba leaves powder 50mg, ginkgo biloba leaves extract 30mg
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
21) 27.02.13
Relaxin Capsules
Each capsule contains: Valerian root 100mg,Passion flower 100mg, chamomile flower 100mg)
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
22) 27.02.13
Senna Leaves High Potency Capsules
Senna leaves 235mg Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT
CLASSIFICATION STATUS
23) 27.02.13
Calcium 600 +D Tablets
Calcium carbonate 600mg,equivalent to 240mg of calcium} Vitamin D 200IU
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Vitamin & Mineral List 2
24) 27.02.13
Black Cohosh 250mg Capsules
Black Cohosh 250mg Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
25) 27.02.13
Vitamin B¹² 1000mcg Tablets
Vitamin B¹² 1000mcg Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 2
26) 27.02.13
Aminopep Forte Liquid
Amino Acid, Multivitamins & Mineral Syrup
Indus Pharmaceuticals, Chennai, India
UniMed Health Care Limited
Vitamins & Minerals
List 2
27) 27.02.13
Alcof-C Cough Syrup
Dextromethorphan Hydrobromide BP 10mg, Cetirizine Hydrochloride BP 5mg, Phenylephrine Hydrochloride BP 5mg, Menthol BP 1.5mg per 5ml.
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Cough suppresant, Nasal Decogestant, Antihistamine
List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS
28)
27.02.13
Alcof-D Cough Syrup
Chlorpheniramine Maleate BP 4mg, Phenylephrine Hydrochloride BP 5mg, Dextromethorphan Hydrobromide BP 10mg, Menthol BP 0.5mg per 5ml
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Antihistamine, Nasal Decogestant, Cough Suppressant
List 2
29)
27.02.13
Capsitop Gel
Capsaicin USP {as capsicum oleoresin} 0.025% w/w, Diclofenac diethylamine BP 1.160% w/w, Levomenthol BP 1% w/w, Methyl Salicylate BP 3% w/w.
Stedman Pharmaceuticals, Pvt. TamilNadu, India
UniMed Health Care Limited
Topical Anesthetic List 2
30)
27.02.13
Sanidex Solution (Activator Powder)
Activated Glutaraldehyde Solution 2% w/v & Activator Powder
Sirmaxo Chemicals, Pvt. Ltd., Thane, India
Lasco Distributors Limited
Sterilant List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT
CLASSIFICATION
STATUS
31)
27.02.13
Herbal Life Formula 2 Multivitamin Complex
Each tablet contains:Calcium Carbonate (37% CA} with Maltodextrin FG 302.58mg, Potassium Gluconate 189.8mg, Microcrystallin Cellulose NF/PH EUR/JP 173.55mg, Magnesium Oxide DC, Granular 125.06mg, Ascorbic Acid {97%} DC 64.43mg, Niacinamide USP/FCC 43.73mg, Zinc Gluconate Granular 41.34mg, Croscarmellose Sodium NF- NON-GMO 24mg, DL-Alpha Tocopheryl Acetate {50%} 23mg, Potassium Glycerphosphate 40% on rice {10%K} 17mg, Magnesium Gluconate Dihydrate 16.23mg, Beta Carotene Beadlets {7.5%} 16mg, Pyridoxine Hydrochloride USP 14.38mg, Biotin {1% TRIT} in Microcrystalline Cellulose 12mg, Stearic Acid {Vegetable grade} NF 12mg, Tocopherols, natural mixed {30%} 12mg, D-Calcium Pantothenate 10.12mg, Silicon Dioxide NF 10mg, Magnesium Stearate NF 10mg, Riboflavin 95%, fine granular on HPMC 10.5mg, Betaine Hydrochloride 10mg,
Manhattan Drug Company Inc., New Jersey
Herbalife International of America Inc
Vitamins, Minerals & Herbs
List 2
Hydoxypropyl Methlcellulose 8.95mg, Thiamine Mononitrate 8.55mg, Lycopene Beadlets 5% VBAF 7.92mg, Ferrous Fumarate Powder 7.06mg, Xangold Lutein 10% GFB 3.96mg, Chromium Chloride {1% CR} on DCP 3.8005mg, Copper Gluconate 3.78mg, L-Selenomethionine {0.5% SE on Calcium Phosphate Dibasic} Kosher 3.57mg, Vanadium Amino Acid Chelate {0.1% Vanadium} 2mg, Inositol 2mg, Choline Bitartrate Coated 2mg, Vitamin D³ GFP {100.000 IU/G} 1.93mg, Potassium Iodide 3% TRIT on Calcium Phosphate Dibasic 1.92mg, Folic Acid {10% TRIT.} 1.66mg, Carrot Powder 1mg, Vegetable Powder 1mg, Soinach Powder 1mg, Glycerine USP {99%}, Kosher 0.99mg, Grape Skin Powder 1mg, Pomegranate Polyphenol Extract Blend 1mg, Citrus Bioflavonoids Powder {25%} 1mg, Cyanocobalamin {1% TRIT. IN DCP} 0.29mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT CLASSIFICATION
STATUS
32) 27.02.13
Male Factor 1000 Capsules
Each tablet contains:Calcium Carbonate (37% CA} with Maltodextrin 0.125 258mg, Green Oat PE 5:1 150mg, Nettle Leaf Extract 5:1 75mg, Ascorbic Acid {99%} 55mg, Sea Buckthorn Powder 50mg, Eleutherococcus Hydroalcoholic Spray-Dried 0.5% 2.5mg, Ginseng Leaf Extract Ginsenosides 30% 2.5mg.
Manhattan Drug Company Inc., New Jersey
Herbalife International of America Inc
Herbal List 2
33) 27.02.13
Green Tea 300mg Capsules
Green tea leaves 300mg per capsule
Alfa Vitamins Laboratories Inc, USA
Facey Commodity Company Ltd
Herbal List 1
DRUGS REGISTERED IN FEBRUARY 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS
27.02.13 Alcof Cough Expectorant
Chlorpheniramine Maleate BP 2.2mg, Ammonium Chloride BP 110mg, Sodium Citrate BP 50mg, Menthol BP 1.1mg per 5ml.
Aurochem Laboratories (India), Pvt. Ltd., India
Inter Commercial Distributors Limited
Expectorant,Antihistamine,
List 1
27.02.13 Benefibre Wheat Dextrin Powder
Wheat Dextrin 100% Powder 3g per serving
Novartis Consumer Health Inc., Nebraska, USA
Cari-Med Limited Dietary Fibre List 1
19.02.13 Incivo Film-Coated Tablets 375mg
Telaprevir 375 mg Janssen_Cilag S.p.A., Via C. Janssen, Latina, Italy
Cari-Med Ltd Antiviral Agent List 4
19.02.13 Valsaden 80mg/12.5mg Film-coated Tablets
Valsartan 80mg, hydrochlorothiazide 12.5mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihypertensive List 4
27.02.13 Valsaden 160mg/12.5mg Film-coated Tablets
Valsartan 160mg, hydrochlorothiazide 12.5mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihypertensive List 4
DRUGS REGISTERED IN MARCH 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT
CLASSIFICATION STATUS
13.03.13
Roswera 5mg Film-coated Tablets
Rosuvastatin Calcium 5mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihyperlipidemic agent
List 4
13.03.13
Health 2000 Simvastatin 40mg Tablets
Simvastatin 40mg USP
Skant Healthcare Ltd., India
Health Brands Limited
Antihyperlipidemic agent
List 4
14.03.13
Roswera 20mg Film-coated Tablets
Rosuvastatin Calcium 20mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihyperlipidemic agent
List 4
14.03.13
Roswera 10mg Film-coated Tablets
Rosuvastatin Calcium 10mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihyperlipidemic agent
List 4
14.03.13
Roswera 40mg Film-coated Tablets
Rosuvastatin Calcium 40mg
Krka d.d., Novo Mesto, Slovenia
Servi-Care Distributors Ltd.
Antihyperlipidemic agent
List 4
15.03.13
Apo-Rosuvastatin 10mg Tablets
Rosuvastatin Calcium 10mg
Apotex Incorporated, Canada
Cari-Med Limited
Antihyperlipidemic agent
List 4
55) 15.03.13
Apo-Rosuvastatin 20mg Tablets
Rosuvastatin Calcium 20mg
Apotex Incorporated, Canada
Cari-Med Limited
Antihyperlipidemic agent
List 4
56) 18.03.13
Lopinavir and Ritonavir 200/50mg Tablets
Lopinavir 200mg, Ritonavir 50mg
Cipla Limited, India Lasco Distributors Limited
Antiviral Agent List 4
57) 18.03.13
Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300mg/300mg
Lamivudine USP 300mg, Tenofovir Disoproxil Fumarate 300mg {equivalent to Tenofovir Disoproxil 245mg})
Cipla Limited, India Lasco Distributors Limited
Antiviral Agent List 4
58) 18.03.13
Abacavir Sulfate and Lamivudine Tablets
Each uncoated tablet contains:Abacavir sulfate {equivalent to abacavir 60mg, Lamivudine USP 30mg})
Cipla Limited, India Lasco Distributors Limited
Antiviral Agent List 4
59) 19.03.13
Levo-Denk 250 Film-Coated Tablets
Each film-coated tablet contains:250mg Levofloxacin {equivalent to 256.23mg levofloxacin hemihydrate})
Rottendorf Pharma GmbH, Germany
H.D. Hopwood and Co. Ltd.
Antibiotic List 4
DRUGS REGISTERED IN MARCH 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION
STATUS
60) 19.03.13
Lancer 30 Delayed Release Capsules
Lansoprazole 30mg USP Aurochem Pharmaceuticals (India), Pvt. Ltd.
Inter Commercial Distributors, Ltd
Proton Pump Inhibitor
List 4
61) 25.03.13
Saphris 5mg Sublingual Tablets
Contains: Asenapine maleate 7.03mg equivalent to asenapine 5mg
Catalent UK Swindon Zydis Ltd., UK
Health Brands Limited
Antipsychotics List 4
62) 25.03.13
Saphris 10mg Sublingual Tablets
Contains: Asenapine maleate 14.06mg equivalent to 10mg asenapine
Catalent UK Swindon Zydis Ltd., UK
Health Brands Limited
Antipsychotics List 4
63) 25.03.13
Cortiflow Inhaler CFC Free
Each actuation delivers Anhydrous Beclometasone Dipropionate B.P., 50mcg, suspended in propellant HFA 134a (1,1,1,2 Tetrafluoroethane)
M/S Midas-Care Pharmaceticals, Pvt., Ltd., Aurangabed, India
Unimed Limited Steroid-inhaled List 4
64) 25.03.13
Sodium Chloride Intravenous Infusion B.P
.9% w/v) NS (Each 100ml contains: Sodium Chloride B.P., 900mg
Ahlcon Parenterals (India) Ltd., Rajasthan, India
Medical Products Limited
Parental Nutrition List 4
65) 25.03.13
Cadigrel Tablets 75mg
Each film-coated tablet contains: Clopidogrel Bisulfate USP {equivalent to Clopidogrel 75mg
Cadila Pharmaceuticals Ltd., Gujarat, India
New Vision Distributors Limited
Antiplatelet Agent
List 4
DRUGS REGISTERED IN MARCH 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT
CLASSIFICATION
STATUS
66) 25.03.13
Intacape 500 Tablets
Each contains: Capecitabine USP 500mg Intas Pharmaceuticals Ltd., India
Lascelles Laboratories Ltd
Anitneoplastics List 4
67) 26.03.13
Implanon Implant 68mg
Each implant contains: 68mg of etonogestrel
N.V. Organon, OSS, The Netherlands
Health Brands Limited
Contraceptive-Progestins
List 4
68) 27.03.13
Posicaine 100 Injection
Contains: Articaine HCI 4% with Epinephrine 1:100,000)
Novocol Pharmaceutical of Canada Inc., Ontario, Canada
Glenn Logan Anaesthetic List 4
69) 27.03.13
Posicaine 200 Injection
Contains:Articaine HCI 4% with Epinephrine 1:200,000
Novocol Pharmaceutical of Canada Inc., Ontario, Canada
Glenn Logan Anaesthetic List 4
70) 27.03.13
Broncochem Flu Remedy Caplets
Acetaminophen 500mg, Bromhexine HCL 8mg, Phenylephrine 5mg, Chlorphenirmine
Magnachem International Laboratory, San Cristobal, Dominican Rep.
Qualcare Limited
Antihistamine,Pain reliever,Mucolytic Agent
List 4
71) 27.03.13
Apo- Escitalopram 10mg Tablets
Contains: Escitalopram Oxalate 10mg Apotex Research Private Ltd., Bangalore, India
Cari-Med Limited
Antidepressant List 4
28.03.13
Cisplatin Injection B.P., 50ml for I.V. Infusion
Each 50ml vial contains: Cisplatin, B.P.50mg
Naprod Life Sciences PVT. Ltd., Dist. Thane, India
Inter Commercial Distributors Ltd.
Antineoplastics List 4
72) 28.03.13
Etoposide Injection U.S.P. 100mg/5ml
Each 5ml vial contains: Etoposide U.S.P,100mg
Naprod Life Sciences PVT. Ltd., Dist. Thane, India
Inter Commercial Distributors Ltd
Antineoplastics List 4
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE5-4-13 Zoteon
Podhaler 28mg Inhalation Powder Hard Capsules
Tobramycin Novartis Pharmaceuticals Corporation, USA
Cari-Med Limited
Respiratory List 4 Adult use; children age 6 and over
5-4-13 Ribomustin 25mg powder for concentrate for solution for infusion
Bendamustine Hydrochloride
Thissen Laboratories SA, Belgium
Cari-Med Limited
Alkylating Agents List 4 Adult use only
5-4-13 Ribomustin 100 mg powder for concentrate for solution for infusion
Bendamustine Hydrochloride
Thissen Laboratories SA, Belgium
Cari-Med Limited
Alkylating Agents List 4 Adult use only
5-4-13 Triben Plus Ear Drops
Overleaf not seen Jenburkt Pharmaceuticals Ltd, India
Pulse Medicine and Surgicals
Otic Antibiotic List 4 Adult use only
5-4-13 Apo-Letrozole 2.5 mg tablets
Letrozole USP Apotex Inc, Canada Cari-Med Limited
Anti-Cancer Agent
List 4 Adult use only
12-4-13 Telma 20 tablets
Telmisartan BP 20 mg Glenmark Pharmaceuticals Limited, India
T. Geddes Grant Distributors Limited
Anti-hypertension List 4 Adult use only
12-4-13 Telma 40 tablets
Telmisartan BP 40 mg Glenmark Pharmaceuticals Limited, India
T. Geddes Grant Distributors Limited
Anti-hypertension List 4 Adult use only
DRUGS REGISTERED IN APRIL 2013
DRUGS REGISTERED IN APRIL 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE12-4-13 Telma 80
tabletsTelmisartan BP 80 mg Glenmark
Pharmaceuticals Limited, India
T. Geddes Grant Distributors Limited
Anti-hypertension List 4 Adult use only
12-4-13 Multiplex Syrup Vitamin A Palmitate USP 1500 IU, Vitamin D3 USP 200 IU, Vitamin B1 BP 1.5mg, Vitamin B2 5’ Phos. Sod. BP 1.75mg, Vitamin B6 BP 0.5mg, Vitamin B12 BP 2.5mcg, Vitamin C BP 25mg, Niacinamide BP 12.5mg, L.Lysine mono Hydrochloride USP 100mg, Zinc Sulphate USP 8.25mg, Vitamin E USP 0.5mg, Dexpanthenol USP 1.00mg
Indus Pharmaceuticals Arlab (India) Pvt, Ltd, Alathur, India
Unimed Health Care Limited
Nutritional List 2 Adult use only
12.4.13 Ardyss-LeVine Green Dietary Supplement
Aloe vera juice (from concentrate) 7.5g, milk thistle extract 180mg, alfalfa herb extract 120mg, artichoke extract 120mg, senna leaf extract 120mg, gamma oryzanol 120mg, licorice extract deglycyrrihizinated 60mg, schizandra berry extract 60mg, ginger root extract 1.5mg, sodium copper chlorophyllin (mulberry leaf extract) 1.2mg; per 30ml
Aseptic Solutions, California, USA
Uni-Med Health Care Limited
Nutritional List 2 Adult use only
12.4.13 Ardyss-Multiplus Dietary
Vitamin A (50% as beta carotene and 50% as vitamin A palmitate) 5,000 IU, vitamin C (as ascorbic
Aseptic Solutions, California, USA
Uni-Med Health Care Limited
Nutritional List 2 Adult use only
Supplement acid) 500mg, vitamin D (as cholecalciferol) 200 IU, vitamin E (as d-alpha tocophreyl acetate) 30 IU, vitamin K (as phytonadione) 40mcg, thiamin (as thiamine phytonadione) 1.5mg, riboflavin (as riboflavin-5 phosphate) 1.7mg, niacin (as niacinamide) 20mg, vitamin B6 (as pyridoxine hydrochloride) 2mg, biotin (as d-biotin) 150mcg, pantothenic acid (as calcium Pantothenate) 10mg, calcium (as calcium chloride) 50mg, magnesium (as magnesium sulfate) 20mg, zinc (as zinc sulfate) 15mg, selenium (as sodium selenite) 70mcg, copper (as cupric sulfate) 1mg, manganese (as manganese chelate) 2mg, chromium (as chromium polynicotinate) 120mcg, potassium (as potassium citrate) 75mg; per 30ml
18-4-13 Ciprocip 500 tablets
Ciprofloxacin hydrochloride equivalent to ciprofloxacin BP 500mg
Flagship Biotech International, India
Uni-Med Distributors Limited
Antibiotic List 4 Age 17 and over
18-4-13 Ranitidine 300mg tablets (BP)
Ranitidine hydrochloride 336 mg equivalent to ranitideine 300 mg
Flagship Biotech International, India
Uni-Med Distributors Limited
H2RB List 4 Adult use only
18-4-13 Ranitidine 150mg tablets (BP)
Ranitidine 150 mg Flagship Biotech International, India
Uni-Med Distributors Limited
H2RB List 4 Adult use only
DRUGS REGISTERED IN APRIL 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE19-4-13 Flogrel 75 mg
tabletsClopidogrel bisulphate 97.87 mg equivalent to clopidogrel 75 mg
Flagship Biotech International, India
Uni-Med Distributors Limited
List 4 Adult use
17-4-13 Thycarzole 5 mg tablets
Carbimazole 5mg BP Unicure Remedies PVT. Ltd India
Health Brands Limited
Anti-Hyperthyroidism
List 4 Adult use only
17-4-13 Air-o-vent Inhaler CFC Free
Overleaf not seen M/S Midas-Care Pharmaceuticals, Aurangabad, India
UniMed Distributors Limited
Respiratory List 4 Adult and children use
19-4-13 Aprovasc 150mg/5mg film coated tablets
Irbesartan 150mg/Amlodipine besilate 5 mg
Sanofi Aventis De Mexico, SA De CV Ocayoacac, Mexico
H.D. Hopwood Anit-hypertension List 4 Adult use only
19-4-13 Aprovasc 300mg/5mg film coated tablets
Irbesartan 300mg/Amlodipine besilate 5 mg
Sanofi Aventis De Mexico, SA De CV Ocayoacac, Mexico
H.D. Hopwood Anit-hypertension List 4 Adult use only
19-4-13 Aprovasc 300mg/10mg film coated tablets
Irbesartan 300mg/Amlodipine besilate 10 mg
Sanofi Aventis De Mexico, SA De CV Ocayoacac, Mexico
H.D. Hopwood Anit-hypertension List 4 Adult use only
19-4-13 Aprovasc 150mg/10mg
Irbesartan 150mg/Amlodipine besilate
Sanofi Aventis De Mexico, SA De CV
H.D. Hopwood Anit-hypertension List 4 Adult use only
film coated tablets
10 mg Ocayoacac, Mexico
DRUGS REGISTERED IN APRIL 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE19-4-13 Intelence
200mg tabletsEtravirine 200 mg Janssen-Cilag S.p.A.
Latina, ItalyCari-Med Limited
Anti-viral List 4 Age 6 and over
19-4-13 Doxorubicin Hydrochloride for injection BP 10mg/vial
Doxorubicin hydrochloride BP 10 mg
Naprod Life Sciences Pvt Ltd Dist Than India
Inter-Commercial Distributors Limited
Anti-Cancer List 4 Adult use only
19-4-13 Doxorubicin Hydrochloride for injection BP 50mg/vial
Doxorubicin hydrochloride BP 50 mg
Naprod Life Sciences Pvt Ltd Dist Than India
Inter-Commercial Distributors Limited
Anti-Cancer List 4 Adult use only
22-4-13 Afinitor 5mg tablets
Everloimus 5mg Novartis Pharma Stein AG Switzerland
Cari-Med Limited
Anti-Cancer List 4 Adult use only
24-4-13 Flucosyst-150 capsule
Fluconazole 150 mg USP Medicamen Biotech Limited Rojasthan, India
Indies Pharma Anti-Fungal List 4 Adult use only
23-4-13 Bioprist Atenolol-50 tablets
Atenolol 50 mg BP Medicamen Biotech Limited Rojasthan, India
Indies Pharma Anti-hypertension List 4 Adult use only
23-4-13 Neutrogena Oil-Free Acne Wash Redness Soothing Facial
Salicylic Acid 2% w/w Vee Pak Inc, USA Cari-Med Limited
List 4 Adult use only
Cleanser LiquidDRUGS REGISTERED IN APRIL 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE18-4-13 Moxflag 500
CapsulesAmoxicillin trihydrate BP 599.37mg equivalent to amoxicillin 500mg BP
Flagship Biotech International, India
UniMed Distributors Limited
Antibiotic List 4 Age 6 and over
23-4-13 Health 2000 Fexophen 180 tablets
Fexofenadine hydrochloride 180 mg BP
Unicure Remedies PVT LTD, India
Health Brands Limited
Antihistamine List 4 Adult use only
29-4-13 Pantoking Injection; for IV use; 40 mg per vial; lyophilized
Pantoprazole sodium USP equivalent to pantoprazole 40mg
M/S Flagship Biotech International, Gujarat, India
Unimed Distributors Limited
Proton pump inbitor
List 4 Adult use only
25-4-13 Health 2000 Doxorubicin Hydrochloride for Injection 10 mg
Doxorubicin hydrochloride USP 10mg
M/S Health Biotech Ltd, Dist Solan, India
Health Brands Limited
Anti-Cancer List 4 Adult use only
15.04.13
Zoteon Podhaler 28mg Inhalation Powder
Contains: Tobramycin Novartis Pharma Schweiz, AG Switzerland
Cari-Med Limited
Antibiotic List 4
DRUGS REGISTERED IN MAY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE1-5-13 Efcure-600
tabletsEfavirenz 600 mg M/S Emcure
Pharmaceuticals Ltd, Pun, India
Servi-Care Distributors Limited
Anti-viral List 4 Adult use only
1-5-13 Meropenem for injection USP 500mg; vials for IV use
Meropenem USP equivalent to meropenem (anhydrous) 500 mg
Mepromax Life Sciences Private Ltd, Selaquil India
T.Geddes Grant Distributors Limited
Antibiotic List 4 Adult use only
1-5-13 Dextrose injection BP 5% w/v (50g/1) for IV use; 500ml plastic bags
Dextrose anhydrous BP 5gm; water for injection BP QS
Ahlcon Parenterals (I) Ltd Rajasthan, India
Medical Products Limited
Parenteral List 4 Adult use only
1-5-13 Sodium chloride (0.9%w/v) and Dextrose (5%w/v) injection BP for IV use; 500ml plastic bags
Overleaf not seen Ahlcon Parenterals (I) Ltd Rajasthan, India
Medical Products Limited
Parenteral List 4 Adult use only
3-5-13 Famy-Depo Contraceptive Injection 1ml vial; IM use only
Medroxyprogesterone acetate USP 150mg
Famy Care Ltd, Ahmedabad, India
Qualcare Limited
Contraceptive List 4 Adult use only
DRUGS REGISTERED IN MAY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE3-5-13 Pirsec
20mg/1100mg capsules
Omeprazole 20mg; sodium bicarbonate 1100mg
Norwich Pharmaceuticals Inc, USA
GSK Caribbean Limited
List 4 Adult use only
3-5-13 Pirsec 40mg/1100mg capsules
Omeprazole 40mg; sodium bicarbonate 1100mg
Norwich Pharmaceuticals Inc, USA
GSK Caribbean Limited
List 4 Adult use only
3-5-13 Edurant 25 mg Film-coated tablets
Rilpivirine Janssen Cilag S.p.A. Italy
Cari-Med Limited
Anti-viral List 4 Adult use only
3-5-13 Inlyta 1mg Film-coated tablets
Axitimib 1mg Pfizer Manufacturing Deutschland, GmbH, Germany
H.D. Hopwood Biologic List 4 Adult use only
3-5-13 Inlyta 5mg Film-coated tablets
Axitimib 5mg Pfizer Manufacturing Deutschland, GmbH, Germany
H.D. Hopwood Biologic List 4 Adult use only
7-5-13 ZincOra Oral Rehydration Salts BP 20.8g, sodium chloride 2.6g, potassium chloride 1.5g, sodium citrate 2.9g, anhydrous glucose 13.5g, orange flavor (dry) 0.3g per sachet
Medicamen Biotech Limited, Rajasthan, India
Indies Pharma Jamaica Limited
Oral Rehydration Salts
List 2 Adult use only
7-5-13 Zinc Ora Zinc sulphate 57 mg USP as monohydrate equivalent to elemental zinc 20 mg tablets
Medicamen Biotech Limited, Rajasthan, India
Indies Pharma Jamaica Limited
Oral Rehydration Salts
List 2 Adult use only
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS
FOR USE7-5-13 L-Montus
tabletsLevocetirizine dihydrochloride 5mg and Montelukast sodium equivalent to Montelukast 10mg
Fourrts (India) Laboratories Pvt. Ltd, Chehnai India
Inter-Commercial Distributors Limited
Respiratory List 4 Adult use only
7-5-13 Infen-25 tablets Dexketoprofen trometamol equivalent to Dexketoprofen 25 mg tablets
Emcure Pharmaceuticals Ltd, Maharashtra, India
Servi-Care Distributors limited
NSAID List 4 Adult use only
9-7-13 Kudose 0.4mg Prolonged Release Capsules
Tamsulosin hydrochloride as modified release pellets 0.4 mg BP
Genpharma International PVT Ltd, India
Medical Products Limited
α- blocker List 4 Adult use only
10-5-13 Firmagon 120mg Powder and Solvent for Solution for injection
Degarelix 120mg as acetate Rentschler Biotechnolagie GmbH, Germany
New Vision Distributors
Anti-Neoplastic Agent
List 4 Adult use only
DRUGS REGISTERED IN MAY 2013
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENT
S FOR USE25-6-13 Jarrow Formulas
Choless Optimizer Tablets
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica Limited
List 2
25-6-13 Jarrow Formulas Pressure Optimizer Tablets
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica Limited
List 1
25-6-13 Sav-Laton Antiseptic Liquid
Cetrimide BP 3% w/v, Chlorhexidine gluconate Solution BP 1.5% equivalent to Chlorehexidine Gluconate 0.3% w/v, Isopropyl Alcohol BP 2.84% w/v)
Shirlome Chemical Corporation Ltd., 63 Hagley Park Rd., Kgn
10, Jamaica
Ayrtons Distributors (Ja.) Co. Ltd.
List 1
25-6-13 Jarrow Formulas Skin Optimizer
Capsules
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica Limited
List 1
25-6-13 Jarrow Formulas Bone-Up Capsules
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica Limited
List 2
25-6-13 Jarrow Formulas
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica
List 2
Vision Optimizer Capsules
Limited
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMNTS FOR USE
25-6-13 Jarrow Formulas Neuro Optimizer
Capsules
Jarrow Formulas, Inc., California, USA
Leading Brands Jamaica Limited
List 2
25-6-13 Systane Gel Drops Lubricant Eye Gel (Sterile)
Polyethylene Glycol 400 NF, 0.4% w/v,Propylene Glycol USP 0.3% w/v.
Alcon Laboratories, Inc., Texas, USA
Cari-Med Limited
List 2
25-6-13 Health 2000 Fexophen 120 Tablets
(Fexofenadine Hydrochloride 120mg USP)
Unicure Remedies Pvt. Ltd., Baroda, India
Health Brands Limited
Histamine blocker List 2
25-6-13 Relcer Gel Vanilla Flavour
Glenmark Pharmaceuticals Limited, Mumbai, India
T. Geddes Grant Limited
List 2
25-6-13 Diabetes Formula Capsules
First Priority Manufacturer’s, Washington, USA
BioTech R&D Institute Ltd.
List 2
25-6-13 Nature’s Pearl Premium Muscadine Grape Seed Capsules
Ground Muscadine Grape Seed 100% [vitis rotundifolia] 650mg
Nature’s Pearl Corporation, North Carolina, USA
Nature’s Pearl Corporation
List 1
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FORUSE
25-6-13 Vidatox 30CH Homeopathic Product Sublingual Drops
Venom of rhopalurus junceus 30CH/0.01ml
Business Groups for Biopharmaceutical and Chemical Production,LABIOFAM Vimang Laboratory for Herbal Medicine, Havana, Cuba
Business Groups for Biopharmaceutical and Chemical Production, Havana, Cuba.
List 4
6-6-13 Zelboraf 240mg film-coated
tablets
Vemurafenib Roche S.p.A., Italy Facey Commodity Co. Ltd.
Anti-Neoplastic Agent
List 4
10-6-13 Esmeron 10mg/ml; 10mls solution for IV injection or IV infusion – vials
Each 10ml vial contains: rocuronium bromide 100mg
Hameln Pharmaceuticals, Germany
MSD Sharp & Dohme, GmbH C/o Health Brands
Muscle Relaxant List 4
7-6-13 Apo-Rosuvastatin 5mg Tablets
Rosuvastatin calcium Apotex Incorporated, Canada
Car-Med Limited Anti-Hypercholesterolemic Agent
List 4
11-6-13 Veltam 0.4 modified release tablets
Tamsulosin hydrochloride USP 0.4mg
Intas Pharmaceuticals, India
Lascelles Limited α- blocker
List 4
11-6-13 Olanzapine Sandoz 5mg film-
coated tablets
Olanzapine Sandoz Ilac, Turkey Qualcare Limited Anti-psychotic Agent
List 4
11-6-13 Olanzapine Olanzapine Sandoz Ilac, Turkey Qualcare Limited Anti-psychotic List 4
Sandoz 10mg film-coated
tablets
Agent
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
12-6-13 Beclate 250 inhaler CFC
Free
Beclometasone dipropionate BP 250mcg per actuation
Cipla Limited, India
Lasco Distributors Limited
Respiratory Agent List 4
10-6-13 Singulair 4mg Oral Granules
Montelukast sodium DSM Pharmaceuticals Inc, NC, USA
Health Brands Limited
Respiratory Agent/Leukotrien
e Receptor Antagonist
List 4
14-6-13 Flagmine 60mg Film-
Coated Tablets
Pyridostigmine bromide BP 60mg
Bharat Parenterals
Limited, India
UniMed Distributors Limited
Acetylcholinesterase Inhibitor
List 4
14-6-13 Moxflag Oral Suspension 250mg/5ml;
100ml
Each 5ml of suspension contains Amoxicillin trihydrate BP equivalent to Amoxicillin 250mg
Flagship Biotech International Ltd.,
India
UniMed Distributors Limited
Anti-biotic List 4
17-6-13 Carbimazole 5mg Tablets
Carbimazole BP 5mg Alvita Pharma Private Limited,
India
UniMed Distributors Limited
Anti-thyroid Agent List 4
14-6-13 Neagel Sterile Ophthalmic
Gel
Ganciclovir 0.15% 150mg/100g
Laboratories Poen S.A.C.I.F.I.,
Bermudez, Argentina
T. Geddes Grant Distributors
Limited
Anti-viral Agent List 4
20-6-13 Health 2000 Losartan
Losartan Potassium USP 50mg
Brussels Laboratories Pvt.,
Health Brands Limited
Anti-hypertensive Agent
List 4
Potassium 50mg Tablets
Ltd., India
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
20-6-13 Health 2000 Ciprofloxacin
250mg Tablets
Ciprofloxacin hydrochloride USP equivalent to Ciprofloxacin 250mg
S Kant Healthcare Ltd., India
Health Brands Limited
Anti-biotic List 4
20-6-13 Health 2000 Ciprofloxacin
500mg Tablets
Ciprofloxacin hydrochloride USP equivalent to Ciprofloxacin 500mg
S Kant Healthcare Ltd., India
Health Brands Limited
Anti-biotic List 4
25-6-13 Clinex Lotion 1%
Each 1ml contains: Clindamycin phosphate USP equivalent to Clindamycin 10mg
Aristopharma Limited, Dhaka, Bangladesh
R.A. Williams Distributors Limited
Anti-biotic List 4
25-6-13 Haloperidol Injection BP; Ampoules; IV/IM use
Each 1ml contains: Haloperidol BP, 5mg
M/S Flagship Biotech
International, Maharashtra State, India
UniMed Distributors
Limited
Anti-psychotic List 4
26-6-13 Health 2000 Nifedipine Sustained Release Tablets 20mg
Nifedipine USP, 20mg M/S Brussels Laboratories Pvt. Ltd., Gujarat State, India
Health Brands Limited
Anti-hypertensive Agent
List 4
26-6-13 Health 2000 Amlodipine 5mg Tablets
Amlodipine besylate BP, 5mg S Kant Healthcare Ltd., Gujarat India
Health Brands Limited
Anti-hypertensive Agent
List 4
Health 2000 Amlodipine 10mg Tablets
Amlodipine besylate BP, 10mg
S Kant Healthcare Ltd., Gujarat India
Health Brands Limited
Anti-hypertensive Agent
List 4
DRUGS REGISTERED IN JUNE 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
26-6-13 Efavirenz 600mg/Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets
Aurobindo Pharma Limited,
India
Intercommercial Distributors Ltd
Anti-Retroviral Agent (ARV)
List 4
26-6-13 Pepguard Injection
(Lyophilized); vials; for I.V. use
Each vial contains: Esomeprazole sodium equivalent to Esomeprazole, 40mg
M/S. Flagship Biotech International, Gujarat State, India
Unimed Distributors Ltd.
Proton Pump Inhibitor (PPI)
List 4
28-6-13 Teicobact-400 Injection; vials; for IV/IM use
Each vial contains: Teicoplanin, 400mg
M/S. Flagship Biotech International, Gujarat State, India
Unimed Distributors Ltd.
Anti-biotic List 4
28-6-13 Amoxiclav-Denk 1000/125 Powder for Oral Suspension
Pencef Pharma GmbH, Berlin, Germany
H.D Hopwood Anti-biotic List 4
DRUGS REGISTERED IN JULY 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
01-7-13 Apo-Lansoprazole 15mg Delayed-Release Capsules
Lansoprazole U.S.P., 15mg
Apotex Inc., Ontario, Canada
Cari-Med Limited
Proton Pump Inhibitor (PPI)
List 4
01-7-13 Apo-Lansoprazole 30mg Delayed-
Release Capsules
Lansoprazole U.S.P., 30mg
Apotex Inc., Ontario, Canada
Cari-Med Limited
Proton Pump Inhibitor (PPI)
List 4
01-7-13 Gonapeptyl Depot 3.75mg Powder & Solvent For Suspension for Injection; S.C. or I.M use; Pre-filled syringes
Ferring GmbH, Wittland, Kiel, Federal Republic of Germany
New Vision Distributors Ltd.
Leutinizing Hormone Releasing Hormone(LHRH) analogue
List 4
10-7-13 Arcoxia 30mg Tablets
Etoricoxib 30mg Frosst Iberica, Madrid, Spain
Health Brands Limited
COX II Inhibitor List 4
11-7-13 Health 2000 Dispersible Aciclovir 800mg Tablets
Aciclovir BP 800mg Unicure Remedies PVT Ltd., India
Health Brands Limited
Anti-viral Agent List 4
12-7-13 Glemont – CT5 Montelukast Sodium Glenmark T. Geddes Grant Respiratory List 4
Chewable Tablets {equivalent to Montelukast 5mg}
Pharmaceutical Ltd., India
Ltd. Agent/Leukotriene Receptor Antagonist
DRUGS REGISTERED IN AUGUST 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
07-8-13 Health 2000 Captopril 25mg Tablets
Captopril USP 25mg Skant HealthCare Ltd., India
Health Brands Ltd.
Anti-hypertensive Agent
List 4
09-8-13 Panto-Denk 20 Gastro-Resistant Tablets
Pantoprazole Sodium Sesquihydrate 22.6mg Equivalent to Pantoprazole 20mg
Advance Pharma GmbH, Germany
H.D. Hopwood & Co., Ltd.
Proton Pump Inhibitor (PPI)
List 4
09-8-13 Panto-Denk 40 Gastro-Resistant Tablets
Pantoprazole Sodium Sesquihydrate 45.1mg Equivalent to Pantoprazole 40mg
Advance Pharma GmbH, Germany
H.D. Hopwood & Co., Ltd.
Proton Pump Inhibitor (PPI)
List 4
12-8-13 Simponi Solution for Injection in
Pre-filled Syringes
Golimumab 50mg/0.5ml Baxter Pharmaceuticals Solution, LLC, Indiana
Cari Med Ltd. Human Monoclonal Antibody
List 4
12-8-13 Carvedi-Denk 25 Tablets
Carvedilol 25mg Artesan Pharma GmbH, Germany
H.D. Hopwood Company Ltd.
Anti-hypertensive Agent/β-blocker
List 4
12-8-13 Carvedi-Denk 6.25 Tablets
Carvedilol 6.25mg Artesan Pharma GmbH, Germany
H.D. Hopwood Company Ltd.
Anti-hypertensive Agent/β-blocker
List 4
DRUGS REGISTERED IN SEPTEMBER 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
09-9-13 Quetiapine 200mg Sandoz film-coated tablets
Quetiapine hemifumarate 230.26mg equivalent to Quetiapine 200mg
Sandoz Ilac Sanayi Ve Ticaret, Turkey
Qualcare Limited
Anti-psychotic Agent
List 4
09-9-13 Quetiapine 300mg Sandoz film-coated tablets
Quetiapine hemifumarate 345.39mg equivalent to Quetiapine 300mg
Sandoz Ilac Sanayi Ve Ticaret, Turkey
Qualcare Limited
Anti-psychotic Agent
List 4
09-9-13 Health 2000 Ibuprofen 600mg Tablets
Ibuprofen BP 600mg Skant HealthCare Ltd., India
Health Brands Ltd.
NSAID List 4
17-9-13 Health 2000 Glidon 30 modified release tablets
Gliclazide BP 30mg Unicure Remedies PVT Ltd., India
Health Brands Ltd.
Anti-Hyperglycaemic
Agent
List 4
17-9-13 Health 2000 Glidon 60 modified release tablets
Gliclazide BP 60mg Unicure Remedies PVT Ltd., India
Health Brands Ltd.
Anti-Hyperglycaemic
Agent
List 4
25-09-13
Health 2000 Metformin HCL Extended Release 500mg Tablets.
Metformin hydrochloride USP 500mg
Skant Healthcare Ltd., India
Health Brands Ltd.
Anti-Hyperglycaemic
Agent
List 4
20-9-13 Allocol with Aloe Supreme Allo Products List 1
Vera Chemicals Ltd., Weymouth Close, Kingston 20
Mandeville, Manchester, Jamaica
DRUGS REGISTERED IN OCTOBER 2013
DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
14-10-13
Organo Gold Organic Ganoderma Lucidum Spore Powder Capsules
Reiishi Mushroom {Ganoderma lucidum, spore} 250mg
Reena Enterprise Ltd., o/a Total Health Centre, Ontario, Canada
Organo Gold International (Jamaica) Limited
List 2
14-10-13
Organo Gold Organic Ganoderma Mycelium Capsules
Reiishi Mushroom {Ganoderma lucidum, mushroom 400mg
Reena Enterprise Ltd., o/a Total Health Centre, Ontario, Canada
Organo Gold International (Jamaica) Limited
List 2
14-10-13
Organo Gold Organic Ganoderma Lucidum Capsules
Reiishi Mushroom {Ganoderma lucidum, whole} 250mg
Reena Enterprise Ltd., o/a Total Health Centre, Ontario, Canada
Organo Gold International (Jamaica) Limited
List 2
8-10-13 Fluarix Vaccine Northern Hemisphere2013-2014 Strain Update
GlaxoSmithKline Biologicals, Dresden, Germany
GlaxoSmithKline Caribbean Ltd.
List 4
8-10-13 Xalkori 200mg Capsules
Crizotinib 200mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
H.D. Hopwood Anti-Neoplastic Agent
List 4
8-10-13 Xalkori 250mg Capsules
Crizotinib 250mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
H.D. Hopwood Anti-Neoplastic Agent
List 4
DRUGS REGISTERED IN OCTOBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
10-10-13
Opavia 5 Film-coated Tablets
Olanzapine Ph. Eur 5mg Jubilant Life Sciences Ltd., India
Medical Products Limited
Anti-psychotic Agent
List 4
10-10-13
Opavia 10 Film-coated Tablets
Olanzapine Ph. Eur 10mg Jubilant Life Sciences Ltd., India
Medical Products Limited
Anti-psychotic Agent
List 4
11-10-13
Telmimark 20 Tablets
Telmisartan BP 20mg Marksans Pharma Ltd., India
Health Brands Ltd.
Anti-hypertensive Agent
List 4
11-10-13
Telmimark 40 Tablets
Telmisartan BP 40mg Marksans Pharma Ltd., India
Health Brands Ltd.
Anti-hypertensive Agent
List 4
11-10-13
Telmimark 80 Tablets
Telmisartan BP 80mg Marksans Pharma Ltd., India
Health Brands Ltd.
Anti-hypertensive Agent
List 4
14-10-13
Simponi Solution for Injection in Pre-filled Injector (Pen) (Single use SmartJect Auto-injector) For Subcutaneous Injection.
Golimumab 50mg/0.5ml Baxter Pharmaceuticals Solution, LLC, Indiana, USA
Cari-Med Ltd. Human Monoclonal Antibody
List 4
14-10-13
Tenoretic 50–12.5mg Tablets
Atenolol 50mg, Chlorthalidone 12.5mg
AstraZeneca, S.A de C.V., Fracc. Lomas Verdes, Naucalpan de Juárez, Mexico
Cari-Med Ltd. Anti-hypertensive Agent
List 4
15-10-13
Efavirenz 600mg/Emtricitabine 200mg/Tenofovir Disoproxil fumarate 300mg tablets
Each film coated tablets coantains efavirenz 600mg, Emtricitabine 200mg, Tenofovir disoproxil fumarate 300mg
Aurobindo Pharma Ltd., India
Inter-Commercial
Distributors Ltd.
Anti-Retroviral Agent (ARV)
List 4
DRUGS REGISTERED IN OCTOBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
15-10-13
Auropan Plus Tablets
Hyoscine butylbromide BP 10mg, Paracetamol BP 500mg
Aurochem Laboratories (India) Pvt. Ltd.
Inter-Commercial Distributors Ltd.
List 4
15-10-13
Otrimar Sea Water with Aloe Vera Nasal Spray
5% aloe vare extract, 30% sea water, purified water
SPPH Impasse des Boussenots, Quetigny Cedex, France
Cari-Med Ltd. List 4
15-10-13
Epiduo Gel Pump 0.1%/2.5%
Adapalene 0.1%, Benzoyl Peroxide 2.5%)
G Production Inc., Canada
Cari-Med Ltd. Dermatologic Agent
List 4
16-10-13
Anzavir R 300mg/100mg Tablets
Atazanavir (as sulfate) equivalent to Atazanavir 300mg, Ritonavir USP 100mg per film coated tablet
Mylan Laboratories Limited, India
Recharged Distributors Limited
Anti-Retroviral Agent (ARV)
List 4
17-10-13
Nexoz 20 delayed release tablets
Each enteric coated tablet contains
Ind-Swift Limited, India
Indies Pharma Jamaica Limited
Proton Pump Inhibitor (PPI)
List 4
Esomeprazole Magnesium Trihydrate equivalent to Esomeprazole to 20mg
17-10-13
Nexoz 40 delayed release tablets
Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate equivalent to Esomeprazole to 40mg
Ind-Swift Limited, India
Indies Pharma Jamaica Limited
Proton Pump Inhibitor (PPI)
List 4
23-10-13
Health 2000 Digilan 125mcg
Tablets
Digoxin, B.P., 125mcg M/S. Unicure Remedies Pvt. Ltd., Baroda, India
Health Brands Ltd.
Cardiac Glycoside List 4
DRUGS REGISTERED IN OCTOBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
24-10-13
Diovan 320mg Tablets
Valsartan 320mg Novartis Farmacéutica S.A., Barcelona, Spain
Cari-med Limited
Anti-hypertensive Agent
List 4
30-10-13
Benefix 250 IU powder and solvent for solution for injection – IV use
Each vial contains 250IU nonacog alfa {recombinant coagulation factor IX}; 1 vial + 1 prefilled syringe + 1 injection set
Powder Manufacturer: Wyeth Farma S.A., Spain; Manufacturer of solvent/ diluent: Vetter Pharma-Fertigung GmbH & Co KG., Germany
H.D. Hopwood List 4
30-10-13
Benefix 500 IU powder and solvent for solution for injection – IV use.
Each vial contains 500IU nonacog alfa {recombinant coagulation factor IX}; 1 vial + 1 prefilled syringe + 1 injection set
Powder Manufacturer: Wyeth Farma S.A., Spain; Manufacturer of solvent/ diluent: Vetter Pharma-Fertigung GmbH & Co KG., Germany
H.D. Hopwood List 4
30-10-13
Irlara 35mg modified release film-coated tablets.
Trimetazidine dihydrochloride BP 35mg
Genpharma International Pvt. Ltd., India
Medical Products Limited
Anti-anginal Agent
List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS REQUIREMENTS FOR USE
12-11-13
Prantel Suspension Each 1 ml contains: Pyrantel embonate Ph. Eur., 14.4mg equivalent to Pyrantel 5mg; Febantel, 15mg
For M/S. Cipla Ltd., Maharashtra, India by M/S. Mistair Health & Hygiene Ltd., Kolhapur, India
Lasco Distributors Ltd.
Anthelmintic Agent
List 2
12-11-13
Cofenac Gel Diclofenac diethylamine, B.P., 1.16% w/w
M/S. Cipla Ltd., Verna, Goa, India
Lasco Distributors Ltd.
Analgesic Agent (Rub)
List 2
equivalent to Diclofenac sodium, B.P., 1% w/w
26-11-13
KomeFast Super Toning Cream
Hydroquinone 1.9% Orion Sales Limited, Delisser Avenue, Yallas,
St. Thomas
Orion Sales Limited
Dermatologic Agent
List 2
12-11-13
Febuday 80 Tablets
Febuxostat 80mg M/S. MSN Laboratories Ltd., Bollaram, India
Lasco Distributors Limited
List 4
12-11-13
Febuday 40 Tablets
Febuxostat 40mg M/S. MSN Laboratories Ltd., Bollaram, India
Lasco Distributors Limited
List 4
12-11-13
Otibact Ear Drops Each 1ml contains: enrofloxacin 5mg; silver sulfadiazine, U.S.P., 10mg
M/S. Cipla Ltd., Bhiwandi, India, by M/S. Vardhaman Remedies Pvt. Ltd., Maharashtra, India
Lasco Distributors Limited
Anti-biotic List 4 For Veterinary Use Only
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
13-11-13
Pantonex DR-20 Delayed-Release Tablets
Pantoprazole sodium sesquihydrate EP equivalent to pantoprazole 20mg
IPCA Laboratories Ltd., Silvassa, India
Servi-Care Distributors Ltd.
Proton Pump Inhibitor (PPI)
List 4
13-11-13
Pantonex DR-40 Delayed-Release
Pantoprazole sodium sesquihydrate EP
IPCA Laboratories Ltd., Silvassa,
Servi-Care Distributors Ltd.
Proton Pump Inhibitor (PPI)
List 4
Tablets equivalent to pantoprazole 40mg
India
13-11-13
Simvastatin Tablets 10mg
Simvastatin EP 10mg Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-Hypercholesterolemic Agent
List 4
13-11-13
Simvastatin Tablets 20mg
Simvastatin EP 20mg Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-Hypercholesterolemic Agent
List 4
13-11-13
Losartan Potassium Tablets
25mg
Losartan potassium Ph. Eur. 25mg
Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-hypertensive Agent
List 4
13-11-13
Losartan Potassium Tablets
50mg
Losartan potassium Ph. Eur. 50mg
Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-hypertensive Agent
List 4
13-11-13
Valtan-80 Tablets Valsartan Ph. Eur. 80mg Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-hypertensive Agent
List 4
13-11-13
Valtan-320 Tablets Valsartan Ph. Eur. 320mg
Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Anti-hypertensive Agent
List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
14-11-13
Pleniva-20 Gastro-Resistant Tablets
Pantoprazole sodium sesquihydrate Ph. Eur. equivalent to pantoprazole 20mg
Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Proton Pump Inhibitor (PPI)
List 4
14-11-13
Pleniva-40 Gastro-Resistant Tablets
Pantoprazole sodium sesquihydrate Ph. Eur. equivalent to pantoprazole 40mg
Jubilant Life Sciences Ltd., Uttarakhand, India
Medical Products Ltd.
Proton Pump Inhibitor (PPI)
List 4
13-11-13
Dorzopt Eye Drops Solution
Each 1ml contains 22.3mg (2%) Dorzolamide hydrochloride equivalent to Dorzolamide 20mg
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-glaucoma Agent
List 4
13-11-13
Dorzotim Eye Drops Solution
Each 1ml contains 22.26mg (2%) Dorzolamide hydrochloride equivalent to Dorzolamide 20mg Timolol maleate 6.83% (0.59%) equivalent to 5mg Timolol
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-glaucoma Agent
List 4
15-11-13
Latanopt 0.005% Sterile Eye Drops
Each 1ml contains Latanoprost 50mcg
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-glaucoma Agent/Intra-ocular
Hypertension
List 4
15-11-13
Simvast 10mg Tablets
Simvastatin Ph. Eur. 10mg
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-Hypercholesterolemic Agent
List 4
15-11-13
Simvast 20mg Tablets
Simvastatin Ph. Eur. 20mg
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-Hyperlipidemic Agent
List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
15-11-13
Simvast 40mg Tablets
Simvastatin Ph. Eur. 40mg
M/S. Indoco Remedies Ltd., Verna, Goa, India
Indies Pharma Ja. Ltd.
Anti-Hypercholesterolemic Agent
List 4
12-11-13
LH 5000 (Softec III) Posterior Chamber Intraocular Lens
Lenstec (Barbados) Inc., Christ Church, Barbados
Clear Horizon Ltd.
List 4
21-11-13
Biograst Injection 300mcg in a Pre-filled Syringe; Biograst Injection 300mcg in a Pre-filled Syringe;
Recombinant Human Granulocyte Colony Recombinant Human Granulocyte Colony
Beijing Four Pharmaceutical Co. Ltd., Beijing City, China
Indies Pharma Ja. Ltd
List 4
21-11-13
Complera 200mg/25mg/300mg Tablets
Emtricitabine 200mg; rilpivirine 25mg; tenofovir disoproxil fumarate 300mg
Patheon Inc., Mississauga, Canada
H.D. Hopwood Anti-Retroviral Agent (ARV)
List 4
21-11-13
Des’ Air Tablets Desloratadine INN 5mg Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Histamine Blocker List 4
21-11-13
Des’ Air Syrup Desloratadine INN 25mg/5ml
Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Histamine Blocker List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
22-11- Biosporine oral Cyclosporine U.S.P., Incepta Indies Pharma Immunosuppressan List 4
13 solution 100mg/1ml Pharmaceuticals Ltd., Dhaka, Bangladesh
Ja. Ltd. t
22-11-13
Fusitop – H Cream Each 1gm contains: Fusidic Acid, B.P., 20mg; Hydrocortisone acetate, B.P., 10mg
Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Topical Anti-biotic List 4
22-11-13
Budison Nebules Nebuliser Suspension 1mg/2ml
Each 2ml ampoule conatins Budesonide B.P., 1mg
Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Respiratory Agent List 4
22-11-13
Budinase Nasal Spray, 120 metered sprays
Each actuation delivers budesonide, B.P., 100mcg
Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Respiratory Agent List 4
22-11-13
Curinac 0.1% Cream
Adapalene INN 1mg per gram
Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Dermatological Agent
List 4
25-11-13
Amloval 5/160 Tablets
Amlodipine besilate, B.P., equivalent to Amlodipine 5mg; Valsartan, U.S.P., 160mg
Popular Pharmaceuticals Ltd., Dhaka, Bangladesh
Indies Pharma Ja. Ltd.
Anti-hypertensive Agent
List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
25-11-13
Amloval 10/160 Tablets
Amlodipine besilate, B.P., equivalent to
Popular Pharmaceuticals
Indies Pharma Ja. Ltd.
Anti-hypertensive Agent
List 4
Amlodipine 10mg; Valsartan, U.S.P., 160mg
Ltd., Dhaka, Bangladesh
25-11-13
Acarbay 25 Tablets
Acarbose, B.P., 25mg IND-Swift Ltd., Samba (Jammu), India
Indies Pharma Ja. Ltd.
Anti-Hyperglycaemic
Agent
List 4
25-11-13
Acarbay 50 Tablets
Acarbose, B.P., 50mg IND-Swift Ltd., Samba (Jammu), India
Indies Pharma Ja. Ltd.
Anti-Hyperglycaemic
Agent
List 4
26-11-13
Prezista 800mg film coated tablets
Darunavir ethanolate 867.28mg corresponding to 800mg Darunavir
Janssen Ortho LLC, Gurabo, Puerto Rico
Cari-Med Limited
Anti-Retroviral Agent (ARV)
List 4
26-11-13
Pantosec 20mg tablets
Each tablet contains Pantoprazole sodium sesqui- hydrate USP 22.55mg equivalent to Pantoprazole 20mg
Incepta Pharmaceuticals Ltd., Bangladesh
Indies Pharma Ja. Ltd.
Proton Pump Inhibitor (PPI)
List 4
26-11-13
Pantosec 40mg tablets
Each tablet contains Pantoprazole sodium sesqui- hydrate USP 45.1mg equivalent to Pantoprazole 40mg
Incepta Pharmaceuticals Ltd., Bangladesh
Indies Pharma Ja. Ltd.
Proton Pump Inhibitor (PPI)
List 4
27-11-13
Biocaltrol 0.25 Capsules
Calcitriol, B.P., 0.25mcg Incepta Pharmaceuticals Ltd., Bangladesh
Indies Pharma Ja. Ltd.
List 4
DRUGS REGISTERED IN NOVEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
27-11-13
Biopofol Emulsion for IV Administration
Each 20ml vial contains propofol, B.P., 200mg
Popular Infusions Ltd., Tongi, Bangladesh
Indies Pharma Ja. Ltd
General Anaesthetic
List 4
28-11-12
Venalon 500 Tablets
Each tablet contains Diosmin (micronized) BP
Incepta Pharmaceuticals
Indies Pharma Ja. Ltd
Venotropic Agent List 4
450mg; Hesperidin BP 50mg
Ltd., Bangladesh
22-11-13
Softec HD Posterior Chamber Intraocular Lens
Ethoxy 2 Hydrox Benzo 1%, Azo Iso Butyronitrile 0.11%, Ethylene Glyco Dimethacrylate0.42%, 2-Hydroxy Ethyl Methacrylate 85.58%, Methyl Methacrylate 14%
Lenstec (Barbados) Inc., Christ Church, Barbados
Clear Horizon Ltd.
List 4
22-11-13
Softec 1 Posterior Chamber
Intraocular Lens
Acryloxy Ethoxy 2 Hydrox Benzo 1%, Azo Iso Butyronitrile 0.11%, Ethylene Glyco Dimethacrylate0.42%, 2-Hydroxy Ethyl Methacrylate 85.58%, Methyl Methacrylate 14%
Lenstec (Barbados) Inc., Christ Church, Barbados
Clear Horizon Ltd.
List 4
DRUGS REGISTERED IN DECEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
3-12-13 Barzithro 500 Tablets
Azithromycin 500mg USP Flamingo Pharmaceuticals Ltd., India
Supreme Chemicals Limited
Anti-biotic List 4
3-12-13 Cozaar XQ Amlodipine camsylate Hanmi Pharma Health Brands Anti-hypertensive List 4
5/100mg Tablets 7.84mg; Losartan potassium100mg
Co. Ltd., (Paltan site), Gyeonggi-do, Republic of Korea (manufacturer
Limited Agent
3-12-13 Cozaar XQ 5/50mg Tablets
Amlodipine camsylate 7.84mg; Losartan potassium50mg
Hanmi Pharma Co. Ltd., (Paltan site), Gyeonggi-do, Republic of Korea (manufacturer
Health Brands Limited
Anti-hypertensive Agent
List 4
5-12-13 Health 2000 Alpramark 0.25mg Tablets
Alprazolam EP 0.25mg Marksans Pharma Ltd., India
Health Brands Limited
Anti-anxiety Agent List 4
5-12-13 Health 2000 Alpramark 0.50mg Tablets
Alprazolam EP 0.50mg Marksans Pharma Ltd., India
Health Brands Limited
Anti-anxiety Agent List 4
5-12-13 Mycon Oral Gel 2% w/w
Miconazole BP 2% w/w {miconazole 20mg per gram
Aristopharma Ltd., Bangladesh
R.A. Williams Distributors
Anti-fungal Agent List 4
10-12-13
Bronculair 10mg Tablets
Montelukast sodium 10.4mg equivalent to Montelukast IH 10mg
Marksans Pharma Ltd., India
Health Brands Limited
Respiratory Agent/Leukotriene Receptor Antagonist
List 4
11-12-13
Baramlo 5 Tablets Amlodipine besilate 6.93mg equivalent to Amlodipine BP 5mg
Flamingo Pharmaceuticals Limited, India
Supreme Chemicals Limited
Anti-hypertensive Agent
List 4
DRUGS REGISTERED IN DECEMBER 2013
DATE PRODUCT GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE
11-12-13
Baramlo 10 Tablets
Amlodipine besilate 13.87mg equivalent to
Flamingo Pharmaceuticals
Supreme Chemicals
Anti-hypertensive Agent
List 4
Amlodipine BP 10mg Limited, India Limited11-12-
13Renvela 800mg Film-Coated Tablets
Sevelamer carbonate 800mg
Genzyme Ireland Ltd., Waterford, Ireland
H.D. Hopwood Phosphate binding Agent
List 4
12-12-13
Stelara 45mg/0.5ml Solution for injection in pre-filled syringe – for SC use.
Ustekinumab 45mg/0.5ml
Cilag AG, Switzerland
Cari-Med Limited
Human monoclonal anti-body
List 4
13-12-13
Fusidate H Cream Fusidic acid 2%, hydrocortisone acetate BP 1%
Aristopharma Limited, Bangladesh
R.A. Williams Distributors Ltd.,
Anti-biotic List 4
13-12-13
Barfurox 250mg Tablets
Cefuroxime axetil USP 315mg equivalent to cefuroxime 250mg
Flamingo Pharmaceuticals Ltd., India
Supreme Chemicals Limited
Anti-biotic List 4