usfda finds several violations in aurobindo sterile sun pharma … · 2019. 12. 12. · hyderabad:-...

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www.medicaldarpan.com Dr. Reddy’s Laboratories enters Nutrition Segment with Celevida in India Hyderabad:- Dr. Reddy’s Laboratories Ltd. Mob:- 09058458612, 09307668480, 09305955262, 09761760618 announced the entry into the nutrition segment with the launch of its diabetes nutrition drink ‘Celevida’ in India. It’s a first-of-its-kind under Dr. Reddy’s nutrition portfolio and clinically proven to help manage blood glucose levels among Indian patients. The brand ‘Celevida’ is derived from two words ‘Celebration’ and ‘Vida’*, which means ‘Celebrate Life’. It is available in two flavors – Kesar Elachi and Chocolate, which are taste tested with 300+ diabetics and prediabetics1 . M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories said, “We are pleased to mark our foray into the nutrition segment with Celevida, which will address unmet nutrition needs of the patients in India. Through this nutrition drink, we continue to work towards making a positive impact on people’s health and quality of life.” Dr. Reddy’s Celevida is formulated to have high protein (28-30%), high fiber (12-18%) and slowly digested carbohydrates, which will support in managing the postprandial blood glucose response and satiety2 . The product contains high amount of plant protein that comes from Soy, Ragi and Gram flours. The product has 20 vitamins and minerals, and ingredient such as Folate, Iron, Magnesium, Pantothenic acid, Riboflavin, Vitamin B12, Vitamin B6 and Vitamin C that would fur- ther support in managing tiredness and fatigue3 . Diabetes is a growing challenge in India with a large diabetic (around 73 million) and pre-diabetes population (around 80 million people) and we are estimated to have world’s largest diabetes population by 20354 . What is contributing to the rise of diabetes in the growing population is the changing habits of diet and a sedentary lifestyle. The Indian Council of Medical Research has recommended that, the daily diet of an adult should contain at least 60g of protein and 40g of dietary fibre (based on a 2000 Kcal diet)5. Sun Pharma Reports Q2FY20 Results Q2 Gross Sales at Rs. 7,949 crores up 16% YoY Q2 Net Profit at Rs. 1,064 crores up 12.6% YoY Mumbai, November 07, 2019: Sun Pharmaceutical Industries Ltd. Mob:- 09958124414, 09412480312 reported financials for the sec- ond quarter & first half ending September 30th, 2019. Highlights of Q2FY20 consolidated financials l Sales / Income from operations at Rs. 7,949 crores, a growth of 16% over same quarter last year. l India sales at Rs. 2,515 crores, growth of 35% over Q2 last year. l US finished dosage sales at US$ 339 million, flat over Q2 last year. l Emerging Markets sales at US$ 201 million, up by 3% Q2 last year. l Rest of World sales at US$ 161 million, growth of 49% over Q2 last year. l R&D investments at Rs. 488 crores (6.1% of sales) compared to Rs. 452 crores (6.6% of sales) for Q2FY19. l EBITDA at Rs. 1,616 crores up by 12% over Q2 last year, with resulting EBIT- DA margin of 20.3%. l Net profit for quarter at Rs. 1,064 crores, with resulting net profit margin at 13.4%. Adjusted for the exceptional item of Rs. 1,214 crores for Q2 last year, net profit growth was 12.6%. Highlights of H1FY20 consolidat- ed financials l Sales / Income from operations at Rs. 16,208 crores, growth of 16% over same period last year. l India sales at Rs. 4,828 crores, up by 20% over H1 last year. l US finished dosage sales at US$ 763 million up by 6% over H1 last year. l Emerging Markets sales at US$ 394 million up by 1% over H1 last year. l Rest of World sales at US$ 328 million, growth of 52% over H1 last year. l EBITDA at Rs. 3,496 crores up by 18% over H1 last year, with resulting EBITDA margin of 21.6%. l Net profit for H1FY20 at Rs. 2,452 crores, with resulting net profit margin at 15.1%. Adjusted for the exceptional item of Rs. 1,214 crores for H1 last year, net profit growth was 22.5%. These results were taken on record by the Board of Directors at a meeting held in Mumbai today. Dilip Shanghvi, Managing Director of the Company said, “Our Q2 and H1 per- formance demonstrates sustained growth momentum and is in-line with our full- year guidance. We continue to focus on cost savings and efficiency improve- ment to align our generic business with the changing industry dynamics. Simultaneously, we continue to progress on building our global specialty busi- ness. In the US, we recently launched Cequa while Ilumya continues to gain traction. The recently released long-term follow-up clinical data for Ilumya demonstrates sustained response for patients over four-year period with very good safety profile. We are excited about the long term prospects of Ilumya." Aurobindo Pharma Receives USFDA Approval For Guaifenesin Extended-Release Tablets (OTC) Aurobindo Pharma Limited Ph.:- +91 (40) 66725000 is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin extended- release tablets, 600 mg and 1200 mg (OTC). Aurobindo’s Guaifenesin extended-release tablets are the AB rated generic equivalent of RB Health (US) LLC’s Mucinex® tablets. The product is expected to launch in Q4FY20. Guaifenesin extended-release tablets helps to loosen phlegm (mucus), and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. The approved product has an estimated market size of US$ 301 million for the twelve months ending July 2019, according to IRI database. This is the 10 th ANDA (including 1 tentative approval) approved out of Unit X formulation facility in Naidupet, Andhra Pradesh, India used for manufacturing oral products. Aurobindo now has a total of 419 ANDA approvals (392 Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA. USFDA Finds several Violations In Aurobindo Sterile Injections Unit NEW DELHI:- The US Food and Drug Administration has observed several violations and shortcomings in Aurobindo Pharma’s sterile injections facility in Pashamylaram, Hyderabad, in yet another setback for the firm. FDA investigators have observed vio- lations in sterilisation process to prevent microbial contamination and shortcomings in facility management procedures along with major protocol lapses in its sterile unit. The same unit had come under the FDA radar in March 2018. The inspection at Unit IV from November 4-13 found “procedures designed to prevent microbial contamina- tion of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilisation process .. ,” said the Form 483 ‘inspectional observation’ report. EThas seen a copy of the Form 483 issued to Aurobindo Pharma. It said the unit does not follow established test procedures, and that senior company managers confirmed to investiga- tors that cleaning and sanitising is not done peri- odically. Form 483 list- ed 14 observations. Specifically, it found records of inspections of automatic, mechanical or electron- ic equipment, including computers or related sys- tem were not maintained. “The quality control unit lacks authori- ty to review production records to assure that no errors have occurred and fully investigate errors that have,” it said. ET first report- ed about the FDA inspections at the plant on November 5. Aurobindo did not respond to ET’s emailed queries as of press time Friday. FDA investigators also found that the laboratory does not perform enough quality control check to ensure analysts are per- forming tests adequately on a consistent basis. “Laboratory records are deficient in that they do not include the initials and signatures of the person performing the tests and dates tests were performed,” the report said. It also noted that employees are not given training in particular operations they perform, and observed lapses in the leach- ability studies and biocompatibility studies. The unit IV is Aurobindo’s key injectable formulations plant, accounting for 9-10% of the firm’s US sales and 50-60% of its total injectable sales in FY19. The plant also accounted for 8-9% of the company’s overall operating profit during the period. Aurobindo will now have to respond to FDA with corrective measures to get the plant cleared within a stipulated time.

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Page 1: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

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Dr. Reddy’s Laboratories enters Nutrition Segmentwith Celevida in India

Hyderabad:- Dr. Reddy’s Laboratories Ltd. Mob:-09058458612, 09307668480, 09305955262, 09761760618announced the entry into the nutrition segment with the launch ofits diabetes nutrition drink ‘Celevida’ in India. It’s a first-of-its-kindunder Dr. Reddy’s nutrition portfolio and clinically proven to helpmanage blood glucose levels among Indian patients. The brand‘Celevida’ is derived from two words ‘Celebration’ and ‘Vida’*,which means ‘Celebrate Life’. It is available in two flavors – Kesar

Elachi and Chocolate, which are taste tested with 300+ diabetics and prediabetics1 . M VRamana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’sLaboratories said, “We are pleased to mark our foray into the nutrition segment with Celevida,which will address unmet nutrition needs of the patients in India. Through this nutrition drink, wecontinue to work towards making a positive impact on people’s health and quality of life.” Dr.Reddy’s Celevida is formulated to have high protein (28-30%), high fiber (12-18%) and slowlydigested carbohydrates, which will support in managing the postprandial blood glucose responseand satiety2 . The product contains high amount of plant protein that comes from Soy, Ragi andGram flours. The product has 20 vitamins and minerals, and ingredient such as Folate, Iron,Magnesium, Pantothenic acid, Riboflavin, Vitamin B12, Vitamin B6 and Vitamin C that would fur-ther support in managing tiredness and fatigue3 . Diabetes is a growing challenge in India with alarge diabetic (around 73 million) and pre-diabetes population (around 80 million people) and weare estimated to have world’s largest diabetes population by 20354 . What is contributing to therise of diabetes in the growing population is the changing habits of diet and a sedentary lifestyle.The Indian Council of Medical Research has recommended that, the daily diet of an adult shouldcontain at least 60g of protein and 40g of dietary fibre (based on a 2000 Kcal diet)5.

Sun Pharma Reports Q2FY20 ResultsQ2 Gross Sales at Rs. 7,949 crores up 16% YoY Q2 NetProfit at Rs. 1,064 crores up 12.6% YoY Mumbai, November07, 2019: Sun Pharmaceutical Industries Ltd. Mob:-09958124414, 09412480312 reported financials for the sec-ond quarter & first half ending September 30th, 2019.Highlights of Q2FY20 consolidated financials l Sales /Income from operations at Rs. 7,949 crores, a growth of 16%over same quarter last year. l India sales at Rs. 2,515 crores,growth of 35% over Q2 last year. l US finished dosage salesat US$ 339 million, flat over Q2 last year. l Emerging Markets

sales at US$ 201 million, up by 3% Q2 last year. l Rest of World sales at US$161 million, growth of 49% over Q2 last year. l R&D investments at Rs. 488crores (6.1% of sales) compared to Rs. 452 crores (6.6% of sales) for Q2FY19.l EBITDA at Rs. 1,616 crores up by 12% over Q2 last year, with resulting EBIT-DA margin of 20.3%. l Net profit for quarter at Rs. 1,064 crores, with resultingnet profit margin at 13.4%. Adjusted for the exceptional item of Rs. 1,214 croresfor Q2 last year, net profit growth was 12.6%. Highlights of H1FY20 consolidat-ed financials l Sales / Income from operations at Rs. 16,208 crores, growth of16% over same period last year. l India sales at Rs. 4,828 crores, up by 20%over H1 last year. l US finished dosage sales at US$ 763 million up by 6% overH1 last year. l Emerging Markets sales at US$ 394 million up by 1% over H1last year. l Rest of World sales at US$ 328 million, growth of 52% over H1 lastyear. l EBITDA at Rs. 3,496 crores up by 18% over H1 last year, with resultingEBITDA margin of 21.6%. l Net profit for H1FY20 at Rs. 2,452 crores, withresulting net profit margin at 15.1%. Adjusted for the exceptional item of Rs.1,214 crores for H1 last year, net profit growth was 22.5%. These results weretaken on record by the Board of Directors at a meeting held in Mumbai today.Dilip Shanghvi, Managing Director of the Company said, “Our Q2 and H1 per-formance demonstrates sustained growth momentum and is in-line with our full-year guidance. We continue to focus on cost savings and efficiency improve-ment to align our generic business with the changing industry dynamics.Simultaneously, we continue to progress on building our global specialty busi-ness. In the US, we recently launched Cequa while Ilumya continues to gaintraction. The recently released long-term follow-up clinical data for Ilumyademonstrates sustained response for patients over four-year period with verygood safety profile. We are excited about the long term prospects of Ilumya."

Aurobindo Pharma Receives USFDA Approval ForGuaifenesin Extended-Release Tablets (OTC)

Aurobindo Pharma Limited Ph.:- +91 (40) 66725000 is pleased toannounce that the company has received final approval from the US Food& Drug Administration (USFDA) to manufacture Guaifenesin extended-release tablets, 600 mg and 1200 mg (OTC). Aurobindo’s Guaifenesinextended-release tablets are the AB rated generic equivalent of RBHealth (US) LLC’s Mucinex® tablets. The product is expected to launch

in Q4FY20. Guaifenesin extended-release tablets helps to loosen phlegm (mucus), and thinbronchial secretions to rid the bronchial passageways of bothersome mucus and make coughsmore productive. The approved product has an estimated market size of US$ 301 million for thetwelve months ending July 2019, according to IRI database. This is the 10 th ANDA (including 1tentative approval) approved out of Unit X formulation facility in Naidupet, Andhra Pradesh, Indiaused for manufacturing oral products. Aurobindo now has a total of 419 ANDA approvals (392Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.

USFDA Finds several Violations In Aurobindo SterileInjections Unit

NEW DELHI:- The US Food and Drug Administration has observed several violationsand shortcomings in Aurobindo Pharma’s sterile injections facility in Pashamylaram,Hyderabad, in yet another setback for the firm. FDA investigators have observed vio-lations in sterilisation process to prevent microbial contamination and shortcomings infacility management procedures along with major protocol lapses in its sterile unit.The same unit had come under the FDA radar in March 2018. The inspection at UnitIV from November 4-13 found “procedures designed to prevent microbial contamina-tion of drug products purporting to be sterile did not include adequate validation of theaseptic and sterilisation process .. ,” said the Form 483 ‘inspectional observation’report. EThas seen a copy of the Form 483 issued to Aurobindo Pharma. It said theunit does not follow established test procedures, and that senior company managersc o n f i r m e d to investiga-tors that cleaning andsanitising is not done peri-o d i c a l l y . Form 483 list-ed 14 observations.Specifically, it foundrecords of inspections ofautomat ic, m e c h a n i c a lor electron- ic equipment,i n c l u d i n g computers orrelated sys- tem were notmaintained. “The qualitycontrol unit lacks authori-ty to review p r o d u c t i o nrecords to assure thatno errors have occurred and fully investigate errors that have,” it said. ET first report-ed about the FDA inspections at the plant on November 5. Aurobindo did not respondto ET’s emailed queries as of press time Friday. FDA investigators also found that thelaboratory does not perform enough quality control check to ensure analysts are per-forming tests adequately on a consistent basis. “Laboratory records are deficient inthat they do not include the initials and signatures of the person performing the testsand dates tests were performed,” the report said. It also noted that employees are notgiven training in particular operations they perform, and observed lapses in the leach-ability studies and biocompatibility studies. The unit IV is Aurobindo’s key injectableformulations plant, accounting for 9-10% of the firm’s US sales and 50-60% of its totalinjectable sales in FY19. The plant also accounted for 8-9% of the company’s overalloperating profit during the period. Aurobindo will now have to respond to FDA withcorrective measures to get the plant cleared within a stipulated time.

Page 2: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

3 o"kZ rd ?kj cSBs ;g lekpkj i=k i<+us ds fy;s gekjs iatkc uS'kuy cSad] cqyUn'kgj ds iQkekZ niZ.k [kkrk la[;k 1824002100118703] IFSC Code - PUNB0182400 Branch- Deputy Ganj esa gS] esa :ú 250@& tek dj viuk iwjk irk gekjs iQksu uaú& 09410434811 ij SMS dj nsaA

Indian Fharma Fair Pune (Maharashtra) 6 th & 7 th Dec-2019Free Entry For All Visitors

Vedshiv Business Media Pvt Ltd is going to organise Indian Fharma Fair on 6th &amp; 7 th Dec-2019 at Deccan College Ground in Pune ( Maharashtra )This Exhibition will focus to Grow Pharma Business mainly PCD/Franchisee&amp; 3 rd Party Manufacturing in all over Maharashtra. All PharmaProfessionalsare invited to visit this exhibition. Pharma Persons from all overMahrashtra are expected to visit at venue/ Exhibition. This Exhibition isPowered by Sigma Softgel &amp; Formulation and copowered by CascaRemedies Pvt Ltd. This event is done with our Diamond Partner Sarthak Groupof Companies, Platinum Partner Sai Healthcare, Gold Partner Signa MediSolutions (P) Ltd &amp; Silver Partner SB Lifesciences. Supporting Partner

Forgo Pharmaceuticals (P) Ltd and Best Biotech. Printing Partner Graphic Ganga Pvt Ltd. Media PartnerMedical Darpan &amp; The Pharma Chem Monthly. More than 40 Pharma Manufacturing Companies areparticipating in the Exhibition. Following Companies are participating: - Sigma Softgel &amp;Formulation, Casca Remedies, Sarthak Group of Companies, Signa Healthcare, SB Lifesciences, ForgoPharmaceutical (P) Ltd, Best Biotech, Wonder Products, Medicant Nutrients, Vetmed Biotech, ResearchMedicine Pvt Ltd, Fawn Incorporation, Sunvet Healthcare, Iskon Remedies, Bionet India Pvt Ltd, Cu-V-Kar Genetic Medicine, Ethnic Biotech, Syndicate Life Sciences Pvt Ltd, Uni-Pex Pharmaceutical Pvt Ltd,Mestra Pharma Pvt Ltd, Sag Health Science Pvt Ltd, Zoic Life Sciences Pvt Ltd, Matish Healthcare,Puremed Biotech, Devbhoomi Pharmaceuticals, Diksha Ayurveda, V- Care Biotech, Arvincare, QuepreonBiologicals, Liv Well Healthcare, Broad Injectables, Zenacts Pharma Pvt Ltd, Bluebell Pharma, SkinVenture, Nexkem Pharmaceuticals & Janus Biotech (I) Pvt Ltd. For any Query one can Contsct Mr. B.S.

Bhandari (GM) - 9971516888 & Mr. Shivam Sharma (Chief Business Officer) - 9258002828.

dEifu;k¡ ftudh nok lcLVSaMMZ ik;h x;hM/S.Bengal Chemicals & Pharmaceuticals Ltd. Kanpur-208012 (Uttar Pradesh). l M/s Orissa Drugs andChemicals Ltd. Bhubaneswar (Odissa). l M/s Hanuchem Laboralories V.P.O. Solan-173205 (H.P.) l M/sBiogenetic Drugs Pvt.Ltd. Solan-174103 (H.P.) l M/s Park Pharmaceuticals, Solan-174103 (H.P.) l M/sAppasamy Occular Devices (P) Ltd. Solan-173205 (H.P.) l M/s Laboratories Filorga-75008, (Paris France) l M/sMedibios Laboratories Pvt.Ltd. Palghar-401506 (Thane) l M/s Hindustan Aritibiotics Ltd. Pune-411018(Maharashtra). l M/s Curetech Skincare Baddi-173205 (HP). l M/s GNB Medica Labs Solan-174101 (H.P.) lM/s Revat Laboratories Pvt.Ltd. Ongole-523002 (Andhra Pradesh). l M/s Algen Healthcare Limited Sirmour-173030(H.P.) l M/s Rhydburg Pharmaceuticals Ltd. Dehradun (Uttarakhand). l M/s Titans Pharma Una-174507(H.P.) l M/s Macleos Pharmaceuticals Ltd. Ranlpool-737135 (Sikkim). l M/s Glaxo SmithklinePharmaceuticals Limited Nashik-422010 (Maharashtra) l M/s CaremaxForulations Kangra-176501 (H.P.). l M/sOmate Labs Pvt.Ltd. Muzaffarpur-842005 (Bihar). l M/s Eurokem Laboratories Pvt.Ltd. Thiruporur-603110 l M/sLupin Ltd.Boisar-401506 (Palghar). l M/s SynokemPharmaceutical Ltd. Haridwar-249403 (Uttarakhand). l M/sLeben Laboratories Pvt.Ltd. Akola-444104 (Maharashtra). l M/s Jackson Laboratories Pvt. Ltd. Amritsar-143001(Punjab). l M/s Alpa Laboratories Ltd.Indore-453446 (Madhya Pradesh) - Hansraj Mehta, Mob:- 9814132529.

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Page 3: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

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M/S Cardimed (Adivision ofPuremed Biotech) Scon. 6,Opposite City Look Hotel, SaiRoad, Baddi-173205 H.P. Email:

[email protected] Ph.

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puremedbiotech12@ gmail.com

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Page 4: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

Greenleaf FormulationTablets:- CHOLEAF-60K (HOLECALCIFEROL-60000 I.UCHEWABLE TABLET IN ORANGE FLAVOUR) l LEAFCIDJUNIOR 15 (LENSOPRAZOLE 15MG DISPERSIBLE TABLETSIN ORANGE FLAVOUR) l LEAF-CID JUNIOR 30 (LENSOPRA-ZOLE 30MG DISPERSIBLE TABLETS IN ORANGE FLAVOUR)l LEAFCIN-200 (OFLOXACIN 200MG) l LEAFCIN-OZ(OFLOXACIN 200MG, ORNIDAZOLE 500MG) l GRECEFF-100(CEFIXIME 100MG DISPERSIBLE TABLETS) l GRECEFF-200(CEFIXIME 200 MG DT,LACTOBACILLUS 250 MILLIONSPORES DISPERSIBLE TABLETS) l GRECEFF-OF(CEFIXIME 200MG,OFLOXACIN 200MG) l GRECEFF-AZ 250(CEFIXIME 200MG,AZITHROMYCIN 250MG) l GRECEFF-OZ(CEFIXIME 200MG,ORNIDAZOLE 500MG) l GRECEFF-CV(CEFIXIME 200MG, CLAVULANIC ACID 125MG) l CEF-POLEAF-100 (CEFPODOXIME PROXETIL 100MG DIS-PERSIBLE TABLETS) l CEFPOLEAF-200 (CEFPODOXIMEPROXETIL 200MG DISPERSIBLE TABLETS) l CEFPOLEAF-CV (CEFPODOXIME PROXETIL 200MG, CLAVULANIC ACID125MG) l CEFPOLEAF-OF (CEFPODOXIME PROXETIL200MG, OFLOXACIN 200MG) l CEFPOLEAF-AZ (CEFPO-DOXIME PROXETIL 200MG, AZITHROMYCIN 250MG) l LEAF-CLAV-625 (AMOXYCILLIN 500MG,CLAVULANIC ACID 125MG)l LEAFCLAV-375 (AMOXYCILLIN 250MG, CLAVULANIC ACID125MG) l LEAFZOLID-600 (LINEZOLID 600MG) l FAROLEAF(FAROPENAM SODIUM EXTENDED RELEASE 200MG) l SLT-375 (SULTAMICILLIN 375MG) l AZROLEAF-250(AZITHROMYCIN 250MG) l AZROLEAF-500 (AZITHROMYCIN500MG) l LEVOFLAZ-500 (LEVOFLOXACIN 500MG) l

GREXIME-250 (CEFUROXIME AXETIL 250MG) l GREXIME-500 (CEFUROXIME AXETIL 500MG) l LEAFNIM-MD (NIME-SULIDE 100MG MOUTH DISSOLVING TABLET IN ORANGEFLAVOUR) l LEAFNIM-SPAS (NIMESULIDE 100MG, DICY-CLOMINE HCL 10MG) l LEAFNIM-P (NIMESULIDE 100 MG,PARACETAMOL 325 MG) l PAINLEAF-SPAS (DICYCLOMINEHCL 20MG, PARACETAMOL 325MG) l PAINLEAF-650(PARACETAMOL 650MG DISPERSIBLE TABLETS) l

PAINLEAF-1000SR (PARACETAMOL 1000MG SUSTAINEDRELEASE) l LEAFCAM-20 (PIROXICAM 20MG DISPERSIBLETABLETS) l LEAFLAM-PLUS (ACECLOFENAC 100MG, THIO-COLCHICOSIDE 4MG) l LEAFLAM-TH (ACECLOFENAC100MG, PARACETAMOL 325MG, THIOCOLCHICOSIDE 4MG) lLEAFLAM-P (ACECLOFENAC 100MG, PARACETAMOL325MG DISPERSIBLE TABLETS) l LEAFLAM-SP (ACE-CLOFENAC 100MG, PARACETAMOL 325MG, SERRA-TIOPEPTIDASE 15MG) l LEAFLAM-MR (ACE-CLOFENAC 100MG, PARACETAMOL 325MG, CHLOR-ZOXAZONE 250MG) l FINELEAF-P (DICLOFENACPOTASSIUM 50MG, PARACETAMOL 325MG) l FINE-LEAF-SP (DICLOFENAC POTASSIUM 50MG, PARAC-ETAMOL 325MG, SERRATIOPEPTIDASE 10MG) l FINE-LEAF-MR (DICLOFENAC POTASSIUM 50MG, PARAC-ETAMOL 325MG, CHLORZOXAZONE 250MG) l LEAF-DOL-P (TRAMADOL 37.5MG, PARACETAMOL 325MG) lFINELEAF-SPAS (ACECLOFENAC 100MG, DROTAVER-INE 80MG) l XIBOTOR-90 (ETORICOXIB 90MG TABLETCOLOUR ORANGE) l XIBOTOR-120 (ETORICOXIB120MG TABLET COLOUR MAGENTA) l XIBOTOR-PLUS(ETORICOXIB 60MG, PARACETAMOL 325MG) l

XIBOTOR-TH (ETORICOXIB 60MG, THIOCOLCHICO-SIDE 4MG) l GROWSHINE (GROW-AMINO ACID,BIOTIN, CALCIUM PANTOTHENATE, MULTIVITAMINS,MULTIMINERALS) l GREACORT-6 (DEFLAZACORT6MG) l ISOLEAF-40 (SR) (ISOXSUPRINE 40MG SUS-TAINED RELEASE) l TRYMILIN-PLUS (TRYPSIN 48MG,BROMELAIN 90MG, RUTOSIDE TRIHYDRATE 100MG,DICLOFENAC 50MG) l LEAFJOINT (DIACERIN 50MG, MSM250, GLUCOSAMINE 750MG) l GRESPAS-MF (DROTAVER-INE 80MG, MEFENAMIC ACID 250MG) l VOMNICE-MD 4(ONDANSETRON HCL 4MG MOUTH DISSOLVING TABLET INORANGE FLAVOUR) l FULANGIL-150 (FLUCONAZOLE150MG) l FABITAST-40 (FEBUXOSTAT 40MG) l THY-ROLEAF-25 (THYROXINE SODIUM 25MCG) l THYROLEAF-50 (THYROXINE SODIUM 50MCG) l THYROLEAF-100 (THY-ROXINE SODIUM 100MCG) l ZINTOLEAF-COLD (PARACETA-MOL 325MG, LEVOCETIRIZINE 2.5MG, PHENYLEPHRINE10MG, CAFFEINE 30MG) l LEAFNIM-CC (NIMESULIDE100MG, PARACETAMOL 325MG, PHENYLEPHRINE HCL 10MG,CETIRIZINE HCL 5MG, CAFFEINE 25MG) l ZINTOLEAF (LEV-OCETIRIZINE 5MG) l ZINTOLEAF-M KID (LEVOCETIRIZINE2.5MG, MONTELUKAST 4MG) l ZINTOLEAF-M (LEVOCETI-RIZINE 5MG, MONTELUKAST 10MG BILAYERED TABLET) l

ZINTOLEAF-AM (LEVOCETIRIZINE 5MG, AMBROXOL 60MG) lZINTOLEAF-PLUS (LEVOCETIRIZINE 5MG, MONTELUKAST10MG, ACEBROPHYLLINE 200MG (SR) l ZINTOLEAF-FORTE(LEVOCETIRIZINE 5MG, MONTELUKAST 10MG, AMBROXOL75MG) l FEXOGREN-M (FEXOFANADINE120MG,MON-TELUKAST 10MG BILAYERED TABLET) l LINHISTIN-16(BETAHISTINE 16MG) l PREGALEAF-SR (PREGABALIN75MG SUSTAINED RELEASE), METHYLCOBALAMIN1500MCG) l LEAFCOB-NT (PREGABALIN 75MG, NOR-

TRIPTYLINE10MG) l LEAFCOB-ALA (MECOBALAMIN1500MCG, ALPHA LOPIC ACID 100MG, FOLIC ACID 1.5MG,PYRIDOXINE 3MG, THIAMINE 10MG) l LEAFCOB-MNT (PRE-GABALIN 75MG, METHYLCOBALAMIN 1500MCG, NOR-TRIPTYLINE10MG) l LEAFPRIN-40SR (ISOXSUPRINE40MG(SR) l PLEAF-40 (PANTOPRAZOLE 40MG) l PLEAF-D(PANTOPRAZOLE 40MG, DOMPERIDONE 10MG) RABLEAF-20 (RABEPAZOLE 20MG) l RABLEAF-D (RABEPAZOLE20MG, DOMPERIDONE 10MG) Mob.:- +91 9317777888.

Farma HubTablets:- Akon-Xt (Ferrous Ascorbate Eq. to Lron 100mg + FolicAcid 1.5mg) l Amress-Al (Amlodipine 5 gm + Atenolol 50 mg) lAnlin-400 (Theophyllin Prolonged Rekease Ip 400 mg) l

Azixime (Azithromycin 250 mg + Cefixime 200 mg) l AziximeLB (Azithromycin 250 mg + Cefixime 200 mg + Lactic Acid 60

Million Spores) l Azixime Plus (Azithromycin 500 mg + Cefixime200 mg) l Candifine Tf (Ltraconzole 100 mg + Terbinafine 250mg) l Cefafar 250 Cefuroxime Axetil 250mg) l Cefafar 500Cefuroxime Axetil 500mg) l Cefafar Cv 250 (Cefuroxime Axctil250mg + Potassium Clavulanic 125mg) l Cefafar Cv 500(Cefuroxime Axetil 500mg + Potassium Clavulanic 125mg) lCefizan Plus (Cefixime 200mg + ofloxacin 200mg) l Cefizna S(Cefixime 200 mg + Sulbactam 150 mg) l Cefiway 200 Bb(Cefixime 200 mg + Lactic Acid 60 Million Spoers) Cefiway Plus(Cefixime 200mg + Ofloxacin 200mg + Lactic Acid Bacillus) lCefiway Oz (Cefixime 200mg + Omidazole 500mg) l Chestwin(Paracetamol 325mg + Cetirizine 5 mg + Phenylephrine10mg) lClonazan-Et (Clonazepam 0.5mg + Escitalopram Oxalate 10mg)l Defahub 6 (Deflazacort 6mg) l Doxyfine (DoxylamineSuccinate 10mg + Pyridoxine Hydrochloride 10 mg) l Drotyfar-M

(Drotaverone Hcl 80mg + Mefanamic Acid 250mg) l Etohub 0.5(Etizolam 0.5 mg) l Etohub 0.25 (Etizolam 0.25 mg) l Ex-Cv 375(Amoxycillin Trihydrate 250mg + Clavulanic Acid 125mg) l Ex-Cv625 (Amoxycillin Trihydrate 500mg + Clavulanic Acid 125mg) lEx-Cv 625 Lb (Amoxycillin Trihydrate 500mg + Clavulanic AcidBacillus) l Farchav-375 (Amoxycillin Trihydrate 250mg +Clavulanic Acid 125mg) l Farchav-625 (Amoxycillin Trihydrate500mg + Clavulanic Acid 125mg) l Farclav-Kid (AmoxycillinTrihydrate 200mg + Clavulanic Acid 28.5mg) l Farcof Cold(Paracetamol 325 mg + Guaiphenesin 100 mg + Ambroxol 30mg+ Phenylephrine 10 mg + Cpm 10 mg) l Farcort 4(Methyleprednisolone 4 mg) l Farcort 8 (Methyleprednisolone 8mg) l Farcort 16 (Methyleprednisolone 16 mg) l Farcoxia(Etoricoxib 90 mg) l Farnac-forte (Trypsin 48mg + Bromelain90mg + Rutoside 100mg + Diclofenac Potassiun 50mg l Farna-p Aceclofenac 100mg + Paracetamol 325mg) l Farnac-p (Alu-Alu) (Aceclofenac 100mg + Paracetamol 325mg) l Farnac-Mr(Aceclofenac 100mg + Paracetamol 325mg + Chlorzoxazone250mg) l Farnac-sp (Aceclofenac 100mg + Paracetamol 325mg+ Serratiopeptidase 15mg) l Faranc-th4 (Aceclofenac 100mg +Paracetamol 325 mg + Thiocolchicoside 4mg) l Farpod-O(Cefpodoxime Proxetil 200mg + Ofloxacin 200 mg) l Farpod 100(Cefpodoxime Proxetil 100mg) l Farpod 200 (CefpodoximeProxetil 200mg) l Farpod CV (Cefpodoxime Proxetil 200 mg +Pot. Clavulanate 125mg) l Farzyme Pancreatin 170 mg +Activates Dimethicone 80 mg) l Febufar 40 (Febuxostate 40 mg)l Fixim 100 Dt (Cefixime Trihydrate 100mg) l Fixim 200 Dt(Cefixime Trihydrate 200mg) l Fixim 400 (Cefixime Trihydrate400mg) l Fixim-Lb 50 Dt (Cefixime With Lactic Bacillus 50mg) lFixim Plus (Cefixime Trihydrate 200mg + Ofloxacin 200mg) lFungifar 250 (Terbinafine 250 mg) l Fungifar 500 (Terbinafine500 mg) l Glyzan M1 (Glimepride 1 mg + MetforminHydrochloride 500 mg) l Glyzan M2 (Glimepride 2 mg +Metformin Hydrochloride 500mg) l Glyzan Mv1 (Voglibose0.1mg + Glimepride 2.0mg + Metformin Hydrochloride 500mg) lGlyzan Mv2 (Voglibose 0.2 mg + Glimepride 2.0 mg + MetforminHydrochloride 500 mg) l Ishufee (Flupentixol 0.5 mg +Melitracen 10 mg) l Joycin-500 (Levofloxacin 500mg) l JoycinOz (Levofloxacin 250mg + Ornidazole 500 mg) l Kalen (CalciumCitrate 100mg + Calcitrol 0.25mg) l Kalen K2 + (Vitamin K2745mcg + Calcium Citrate 1000mg + L-Methylfolate 1mg + CissusQuadrangularis 500 mg + Vitamin D3 1000 Ui) l Le-Jig

(Levocetrizine 5 mg) l Linifine (Linezolid 600 mg) l

Lumefar (Artemether 80mg + lumefantrine) l Metfar-500(Metformin 500 mg) l Moxyzan 250 DT (AmoxycillinDispersible Tablets 250 mg) l Necfine-p (DiclofenacSodium 50 mg + Serratiopeptidase 10mg + Paracetamol325mg) l Nipafar (Nimesulide 100mg + Paracetamol325mg) l Ketofar (Ketoconazole 200 mg) l Panfar 40(Pantoprazole 40 mg) l Panfar D (Pantoprazole 40 mg +Demeperidone 10 mg) l Parahub 650 (Paracetamol 650mg) l Parahub D (Paracetamol 325 mg + Demoperidone 10mg) l Rabyfar 20 (Rabeprazole 20 mg) l Tamsufar-D(Tamsulosin 0.5 mg + Dustasteride 0.4 mg) l Tanmink 20(Telmisarten 20 mg) l Tanmink 40 (Telmisartan 40 mg) lTanmink 40 H (Telmisartan 40 mg + Hydrochlorothiazide12.5 mg) l Texazan- MF (Tranexamic Acid 500 mg + Mefenamic Acid 250 mg) l Tenzan(Trifluoperazine HCL 1 mg + Chloradiazepoxide 10 mg) lTenifar-20 (Teneligliptin Hydrobromide hydrate 20 mg) lTenifar-M (Teneligliptin Hydrobromide hydrate 20 mg +Metformin 500mg) l Udifine 150 (Ursodeoxycholic Acid150mg) l Udifine 300 (Ursodeoxycholic Acid 150mg) lUdifine 300 (Ursodeoxycholic Acid 300mg) l Udifine SL(Ursodeoxycholic Acid 300mg + Silymarin 140 mg) l

Vertizan 8/16 (Betahistine Hydrochloride Tablets IP 8 mg/16mg) l Veebaz 250 (Azithromycin Dinhydrate 250mg) l

Veebaz 500 (Azithromycin Dihydrate 500mg) l Veebaz 500 Lb(Azithromycin Dihydrate 500mg + Lactic Acid Bacillus) l

Vomifine (Ondansetron 4 mg) l Windfar-Fx (MontelukastSodium 10mg + Fexofenadin Hydrochloride IP120mg) l

Windfar-L (Levocetrizine HCL 5mg + Montelukast Sodium 10mg) l Wisoflox 200 (Ofloxacin 200mg) l Wisoflox-oz (Ofloxacin200mg + Ornidazole 500mg) l Xcitement (Jar) Sildenafil Citrate100 mg) l Xcitement (Strip) Sildenafil Citrate 100 mg) l

Zanofiram (Disulfiram tablets IP) l Zan-M-Spas (Mefenamic Acid250 mg + Dicyclomine Hydrochloride 10 mg) l Zincofar(Vitamins + Minerals + Natural Extract + Nutritional foodSuppliments) Capsules:- Candifine (Itraconazole 100 mg) lCandifine-200 (Itraconazole 200 mg) l Cindaplay-300(Clindamycin 300 mg) l Dirham (Omeprazole 20mg)

Mob:- 08171011413, 09837187230.

Product List

Page 5: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

E-derma Pharma India Pvt. Ltd. Antibiotics - AZICA Tablet : Azithromycin 250/500mg l AUG-FAST Tablet : (Amoxycillin Trih 500mg Potassium Clav. 125mg)l MINOPEARL Tablet : (Minocycline 50/100mg) l METATURNOintment : (Mupirocin 2%) l CEFITURN Tablet : (Cephalexin500 mg) l DALLOX Capsule : (Amoxycillin 250 mg &Dicloxacillin 250 mg) l DYNACLIN Tablet : (Clindamycin150/300 mg) l l DOXYAID-LB Capsule : (Doxycycline Hyclate100mg and 5 billion lactobacillus spores) l FUDICA Cream :(Fusidic acid 2%) l NADIREST Cream : (Nadifloxacin 1%)Antiallergic- E-BEST Tablet : Mizolastine 10 mg l HYBEST-10/25 Tablet : (Hydroxyzine 10/25 mg) l LORAID Tablet :(Loratadine 10 mg) l LEVOCA Tab/Syp : (Levocetirizine 5 mg) lLEVOCA-M Tablet : (Levocetirizine 5 mg & Montelukast 10mg)l POLBEST Tablet : (Dexchlorpheniramine SR 2mg) l FEX-UPTablet : (Fexofenadine 180 mg) l CALOMYNE Lotion :(Calamine 8%, Glycerin 5%, Aloevera 10% ,Liq. Paraffin , ZincOxide 3%) Steroids - DYNACORT Tablet : (Deflazacort6/12/30mg) l SAFECORT Cr/Lot. : (Mometasone Furoate 0.1%)l ECZIVATE 30 Cream : (Clobetasol Prop. 0.05%) l OFICACream : (Fluticasone 0.05%) l HALOTURN Cream :(Halobetasol Prop. 0.05%) l FLUTURN-H Cream :(Fluocinolone Acetonide 0.1%) l NADIREST-M Cream :(Nadifloxacin 1% & Mometasone 0.1%) l DESOCARE Lotion :(Micronised Desonide 0.05%) l ECZIVATE-S Lotion :(Clobetasol 0.05% & Salicylic Acid 3/6%) l HALOTURN Lotion :(Halobetasole Propionate 0.05%) l ISORVATE-AL Gel :(Clobetasol prop. 0.05%, Ammonium Lactate 12%) l FUDICA-BCream : (Fusidic acid 2% & Mometasone Furoate 0.1%)Antifungal - ITRASTAT Capsule : (Itraconazole 100/200mg) lTERBAZ Tablet : (Terbinafine 250 mg) l TERBAZCr/Dust. Powder : (Terbinafine 1%) l KTZ Tablet: (Ketoconazole 200 mg) l KTZ Cr/Dust. Powder: (Ketoconozole 2%) l KTZ Lotion : (Ketoconazole2% Stay on Lotion) l CANBEE Cream :(Clotrimazole 1% , CANBEE-B Cream :Clotrimazole 1% & Beclomethasone 0.025%,SERTAFIX Cream : (Sertaconazole 2.0% & Benzylalcohol 1.0%) l K-WASH Shampoo :(Ketoconazole 2%) l K-WASH PLUS Shampoo :(Ketoconazole 2% & ZPTO 1%) l FLUPACKTablet : (Fluconazole 150 mg) l VORBERG Tablet: (Voriconazole 200 mg) l LUNICOL Cream :(Luliconazole 1%) l AMLOTURN Cream :(Amorolfine 0.025%) Immunosuppressants –AZONY Tablet : (Azathioprine 50 mg) l TACROG-ARD 0.1/0.03 Ointment : (Tacrolimus 0.1/0.03%) lSORAPRIN Softgel Capsule : (Cyclosporine100mg) l NEOTURN 2.5/5/7.5 Tablet :(Methotrexate 2.5/5/7.5 mg) Acne Care - ISO-PEARL-M20 Softgel Cap : (Micronised Isotretinoin20mg) l ISOPEARL-10/20 Softgel Cap :(Isotretinoin 10/20mg) l ISOPEARL-30 SoftgelCap : (Isotretinoin 30mg) l ISOTY Softgel Cap. :(Isotretinoin 20 mg) l DYNACLIN-N Gel :(Clindamycin 1% & Nicotinamide 4%) l DYNACLINGel : (Clindamycin 1%) l O-GYL Gel : (Ornidazole10 mg) l ADAQUEEN Gel : (Adapalene 0.01%) lADAQUEEN-C Gel : (Adapalene 0.01% &Clindamycin 1%) l TRET-A Cream : (Tretinoin0.025%) l AZICA Gel : (Azithromycine 2%) l BEN-ZITURN-AD Gel : (Adapalene 0.1% % benzoyl per-oxide 2.5%) l Benziturn -2.5/5/10 Gel : (Benzoylperoxide 2.5/5/10%) Hyperpigmenting Agents -AZESPOT Cream : Azelaic acid 15 % l FACELITEGel : (Kojic Acid 2%, Arbutin 1.5%, Octinoxate7.5%, Mulberry Extract & Glycolic Acid) l M-LITEPLUS Cream : (Hydroquinone 2%, Tretinoin0.025%) l M-LITE FORTE Cream : (Hydroquinone2%, Tretinoin 0.025% & Mometasone 0.1%) l M-LITE GLOW Cream : (Hydroquinone 2%,Tretinoin0.025% & Fluocinolone Acetonide 0.01%)l M-LITE AT Cream : (Hydroquinone 2%, Tretinoinand Allantoin) l M-LITE Cream : (Hydroquinone2%) l MELOSPOT Cream : (Hydroquinone 4%) lLITEFACE Cream : (Depigmenting Cream) l

GLOW DAY Cream : (Glycolic acid, Alpha Arbutin,Tocopheryl acetate, Resorcinol, Titanium Dioxide) l

GLOW NIGHT Cream : (Alpha Arbutin, Retinol, Liquorice, Vit. E,Glycerine, Squalene, D- alpha Tocopherol, Lenolin) l GLUTA-GLOW Tablet : (Glutathione 500mg and Lipoic acid 200mg) lGLUTAGLOW-C Tablet : (Glutathione 500mg & Vitamin-C500mg) l GLUTAGLOW Peel : (Glutathione 1%, Glycolic acid45%, Lactic Acid 10%, Salicylic acid 0.5%, Kojic Acid Dipalmitate7%, Lemon Peel Ext. 2%, Butyospermum Parkii 5%) l GLUTA-GLOW-C Serum : (Ethyl Ascorbic Acid Stable Vit. C 20%,Glutathione 2%, Niacinamide 2%, Beta-Arbutin 2%, Orange PeelExtract 2%, Lemon Peel Ext. 2%, Dimethicone 2%, ChamomilaExt. 2%) Antioxidants/ Vitamins - LYCOXID Tablet :(Betacarotene (10%) 30 mg, Lycopene (10%) 7500 mcg, Vit. C150 mg., Vit. E 25 mg, Minerals & Zeaxanthine (10%) 25 mg) lPROCDINA Tablet : (Proanthocyanidin 75 mg) l PROCDINA-TX Tablet : (Tranexamic acid 250 mg) l IRONI UP Capsule :(Carbonyl Iron 100 mg, Vit. C 150 mg, Vit. B12 15 mcg., Folic Acid5 mg, Zinc Sulphate 61.8 mg & Vit B6 3 mg) Hair Care - FIN-TURN Tablet : (Finasteride 1 mg) l BIOTURN FORTE Tablet :(Biotin 10 mg, Calcium Pantothenate 100 mg, N-Acetyl Cysteine50 mg, Minerals) l MINTURN-XL Lot/Spray : (Minoxidil 5% &Aminexil 1.5%) l MINTURN-2/5/10 Lot/Spray : (Minoxidil2/5/10%) l HAIR LONG Oil : (Sun flower Oil, Olive Oil, Amla Ext.,Castor Oil, & Grapeseed Oil) l HAIR LONG Tablet : (Beta –Sitosterol 100mg, Manganese 2mg, Vit. E 5mg, Green tea 50mg,Ginkgo biloba 10mg, Nettle leaf extract 50mg, Amino acid,Vitamin B6 3mg, Collagen peptide 50mg & minerals) l HAIRLONG Serum : (Procapil, Keravis, Hydroxyethylcellulose, TributylCitrate, Germall, Propylyene Glycol, Polyquaternium) l HairLong B + Oil : (Biotin, saw palmetto, D -panthenol, SugandhaKokila, Seasame oil, roots of karonday, olive oil) l SOFTUM

Shampoo : (Shea Butter, Ceramides, Soya protein) Soap/Facewash - E-BACTY Soap : (Vit. E, Allantoin & Alum) l ACNE-DAY Soap : (Triclosan, Triclocarben, Glycerin, Vit. E, Aloe Vera& Tree Tea Oil) l GLOWBELLA ALOE VERA Soap : (Aloevera,Vitamin-E, Acetate & Glycerin) l KTZ Soap : (Ketoconazole 1%,ZPTO 0.5%) l SCABICA Soap : (Permethrin 1%) l BEAUTYBar : (Aloe vera, Milk protein, Shea butter, Cocoa butter, Titaniumdioxide, Almond oil, Tree Tea Oil, Vit. E) l GLOWBELLA SOAPSkin Whitening : (Kojic acid, Arbutin, VIT A,C,E & F, Liquorice,Bearberry and Mushroom Extracts.) l SOFTUMBABY/Moisturizer Bar pH 5.5 : (Vit E, Syndet Base, SheaButter, Aloe Butter, Aloe Vera) l VISIA Soap : (Aloe Vera, Vit. E& Moisturising) l VISIA Facewash : (Lemon, Honey, Menthol,Mulberry Extracts) l ACNEDAY Facewash : (D-panthenol,Salicylic, Allantion, Witch Hazel, Aloe vera, Vit E & Triclosan) lSOFTUM Cleansing Lot. : (Cetyl Alcohol 2.65% and stearyl alco-hol 0.265) l GLOWBELLA Skin Whitening Facewash :(Salicylic, Kojic, Lactic and and Glycollic acid) Emollients - VISIACr/Lot. : (Glycerine 6.0%, Tocopheryl Acetate 0.5%, LiquidParaffin 10.0%, Cetyl Alcohol 3.0%, Squalene & Aloe Vera) lVISIA Soft Cream : (Propylene Glycol, Emulsifying wax,Glycerin, Cyclomethicon, ZnO CREAM) l VISIA Lip Balm : (LipCare Lip Balm) l GLOW BELLA moisturizing LOT : (GlycerylMonostearate, Glycerol, Caprylic/Capric Triglyceride, Aloe,Barbadensis Leaf Juice, Stearic Acid, Cetaearyl Alcohol,Butyrospermum Parkii (Shea Butter), Cyclopentasiloxane,Ethylhexylglycerin, Sodium PCA, Tocophery Acetate, DisodiumEDTA, Disodium EDTA, Allantoin For sensitive skin) Sunscreen -O' BAY SPF 30 + Sunscreen : (Octylmethoxycinnamate 5.0%,Avobenzone 2.0%, Methoxy Cinnamidopropyl Hydroxy Sultaine

2.0%, Zinc Oxide 2.0%, Allantion 0.2%, Vitamin E0.1%, Aloe Vera Gel 0.2%, Titanium Dioxide 2%) lVISIA SPF 50 + Sunscreen : (Octinoxate 7.5%,Avobenzone 2%, Oxybenzone 3%,Octocrylene 3%,ZnO 2%, Titanium dioxide 3%) Psoriasis Care –TARSOFT-CS Ointment : (Clobetasol 0.05%,Salicylic Acid 3% & Coal Tar 5%) l ECZIVATE-MFOintment : (Clobetasol 0.05%, Salicylic Acid 3%,Urea 10% & Lactic Acid 3%) l TARSOFT Lotion :(Coal Tar 4.25% & Salicylic Acid 2%) l TARSOFTOintment : (Salicylic Acid 3% & Coal Tar 6%) lCallove Ointment : (Calicipotriol 0.005%)Antiscabies - IVITURN Tablet : (Ivermectin 6/12mg) l PERISH Cream/Lotion : (Permethrin 5%)Antiviral – F-VEER Tablet : (Famciclovir 250mg)Misc - D2 PLUS Tablet : (Diclophenac 50mg,Paracetamol 325 mg & Serratiopeptidase 15mg) lPAPSODOM Tablet : (Pantoprazole 40 mg. &Domperidone 10 mg) l FOUR STROKE Cream :(Ofloxacin 0.75%, Ornidazole 2%, Terbinafine 1% &Clobetasol Prop. 0.05%) l NEW LAUNCH :(MELOSPOT CREAM : Hydroquinone 4%,Octinoxate, Oxybenzone & Titanium Dioxide)

Mob:- 09034435000 09034635000.

SHERYA GERICAREA DIVISION OF SBS BIOTECH

CARDIAC RANGE:- AMOFINE-2.5 (Amoldopine2.5 mg Tab) l AMOFINE-5 (Amlodipine 5 mg Tab) lAMOFINE-10 (Amlodipine 10 mg Tab) l

AMOFINE-AT (Amlodipine 5 mg +ATENOLOL50MG Tab) l AMOFINE - H (Amoldopine 5 mg +Hydrochlorothiazide 12.5mg Tab) l ATINO-25(Atenolol 25 mg Tab.) l ATINO-50 (Atenolol 50 mgTab.) l ATVOC-10 (Atorvastatin 10mg Tab) l

ATVOC-20 ( Atorvastatin 20mg Tab) l ATVOC-40(Atorvastatin 40mg Tab.) l ATVOC-80 ( Atorvastatin80mg Tab.) ATVOC-EZ ( Atorvastatin 10mg +Ezetimibe 10mg Tab) ATVOC-F ( Atorvastatin 10mg+ finofibrate 160 mg Tab(as beta-cyclodextrin)) lATVOC AD -15 (Atrovastatin 10mg + Amlodipine 5mg) l ATVOC AS 85 ( Atrovastatin10mg & AsprinCapsules75mg) l CARNEB-2.5 (Nebivolol 2.5 mgTab.) l CARNEB-5 (Nebivolol 5 mg Tab.) l

CARNEB-H (Nebivolol 5 mg + Hydrochlorthiazide12.5mg Tab) l CLOPU (Clopidogrel 75mg Tab) lCOREL-75 A (Clopidogrel 75mg + Aspirin 75 mgTab) Mob:- 9541810111.

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D.O.B. NAME FIRM MOB. CITY STATE

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eSMhdy niZ.k ehfM;k gkÅl dh rjiQ ls vki lHkh dks tUe fnu dh gkfnZd 'kqHkdkeuk;sa

Happy Birthday

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COPD ls djs cpkoØkWfud vkWClVªfDVo iYeksujh fMtht (lhvksihMh) ,d chekjh ugha gS cfYd chekfj;ksa dk lewg gS- blesa lk¡l uyh dh fldqM+ tkrh gS ftlds dkj.k iQsiQM+s Hkh MSest gksus yxrs gSa ftls ,EiQk;lsek dgrs gSa- ;g chekjh lcls igyslk¡l ysus esa :dkoV iSnk djrh gS- vkSj blds ckn gkVZ o fdMuh vkfn nwljs vaxks dks Hkh uqdlku igqapkrh gSa- ;g chekjh Leksfdax vkSj Leksfdax u djus okys nksuksa esa gksus okyh chekjh gS- lhvksihMh ds y{k.k vkerkSj ij 30 o"kZdh mez ds ckn fn[krs gSa- 'kq: esa lnhZ ds ekSle esa [kkalh] cyxe vkrk gS- blds ckn vDlj lnhZ&tqdke dh leL;k jgrh gS- rhozrk cM+us ij lkal m[kM+rh gS- /weziku djus okys esa lcls vf/d [krjk jgrk gS- /q,a ls ;g chekjhvf/d gksrh gS- ysfdu 40 izfr'kr ,sls ejht gSa tks Leksfdax ugha djrs gSa- /weziku djus okyk vLFkek dk jksxh gS rks mlesa [krjk vf/d jgrk gSa- bl chekjh dk iznw"k.k Hkh cM+k dkj.k gSa- xkaoksa esa pwYgksa ij [kkuk cukus okyhefgykvksa dks [krjk jgrk gS- ,sls O;kikj tgka] /qa, vkSj dSfedy dh xa/ vf/d gksrh gS- blls Hkh [krjk vf/d jgrk gS- blesa iQsiQM+ksa dks uqdlku gksrk gS- /weziku djus okys 4 esa ls ,d O;fDr dks lhvksihMh gksrk gS- /wezikuNksM+ nsa- ?kj esa dhVuk'kd dk fNM+dko ;k jax dk dke py jgk gS rks nwj jgsa- iznwf"kr {ks=kksa esa tkus ls cpsa- fdpu ds /q,a vkSj elkyksa dh xa/ ls cpsa- lk¡l ysus okys O;k;ke fu;fer djsa- bl jksx ls iQsiQM+ksa dh {kerk ?kVrh gSbldks Bhd djus ds fy, bUgsyj dk bLrseky fd;k tkrk gS- iQsiQM+ksa esa laØe.k Hkh vf/d jgrk gS- blesa iwjk iQsiQM+k dke ugha djrk gS rks 'kjhj esa vkWDlhtu dh deh gksrh gS- blds fy, chp&chp esa vkWDlhtu nh tkrh gS-blds vykok tc yax vVSd esa bUgsyj dke ugha djrk gS rks ejht dks d`f=ke lk¡l nsrs gSa [kjkc iQsiQM+ksa dks cqykDVeh esa dkVdj Hkh bykt fd;k tkrk gS- ;g lqfo/k vius ns'k esa Hkh gS- t:jr ds vuqlkj gkVZ dh rjg yaXl esaHkh LVsaV Mkydj bykt fd;k tkrk gS- blesa jksfx;ksa dks ikSf"Vd ,oa larqfyr vkgkj ysuk pkfg,- buesa ,aVh&ck;ksfVd] ,aVhbaÝykesVjh ,oa ,aVh&vkWDlhMsaM~l xq.k okyh phtsa [kk,a- otu c<+us ls ijs'kkuh c<+rh gS- ,sls esa gkbZ izksVhu o yksdSyksjh okyh phtsa gh [kkuh pkfg,- ftudk otu vf/d gS os yks dSyksjh MkbV ysa- blesa rkts iQy [kkus dkiQh ykHknk;d fl} gksrs gSa- tks iQsiQM+ksa ds van:uh elYl dks LoLFk j[krsa gSa vkSj vanj ds uqdlkunk;d inkFkksZ dks ckgjfudkyrs gSa- blfy, gj ekSle ds rkts iQyksa ,oa lfCt;ksa dks Hkjiwj ek=kk esa MkbV esa 'kkfey djsa- MkWñ lw;ZdkUr] ofj"B lkal jksx fo'ks"kK vkSj foHkkxkè;{k-

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www.medicaldarpan.com

November 20-22, 2019 HOSPEX Japan 2019 Koto, Japan. HOS-PEX Japan, held in conjunction with the Conference Healthcareof Engineering Association of Japan, is a comprehensive exhibi-tion including hospital-based facilities, equipment and engineer-ing resources; health and medical treatment information systems;and healthcare and welfare services and support systems. It willbe held at Tokyo Big Sight, Koto, Japan. For details contact:JapanManagement Association, 3-1-22 Shiba Koen, Minatoku,Tokyo 105- 8522, Japan. Tel.: +81-3-3434-1377, Email: [email protected] Website: www.jma.or.jp

November 22-24, 2019 Emirates Dermatology Society AnnualConference 2019 Dubai, UAE.The aim of Emirates DermatologySociety Conference 2019 is to provide a forum of the higheststandard for scientific, educational and social exchange betweenprofessionals involved in Dermatology are in order to achieveprogress in the clinical care of patients. It will be held atInterContinental Dubai Festival City, UAE. For contact details:K.I.T. Group Middle, East FZ LLC, P.O. Box: 77893, TwoFour 54Building, Abu Dhabi, UAE.. Tel.: +971-2245-0057, Email:[email protected] ; Website: www.conference.edsuae.com

November 27-28, 2019 Africa Healthcare Extension Summit2019 Nairobi, Kenya. The 2nd edition of Africa HealthcareExtension Summit will include world class speakers from thehealthcare industry to provide an inside access to what works

today and future trends that will shape and revolutionize thehealthcare sector in Africa region. For details contact: VerveManagement, 2501, HDS Tower, Cluster F, Jumeirah LakesTowers, Dubai, United Arab Emirates. Tel.: +971-4-243-4677/88,E-mail: [email protected] Website:

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November 29-30, 2019 International Oncology Conference 2019Abu Dhabi, UAE. International Oncology Conference features aninterdisciplinary approach, special lectures, debates and interac-tive techniques to explore the controversial, the upcoming, theexciting and the latest evidence and developments in the manage-ment and treatment of Breast, Colon, Lung, Gynecological,Urological, Hematological and Pediatric Cancers. It will be held atGrand Hyatt Hotel & Residences Emirates Pearl, Abu Dhabi,UAE. For details contact: Mena Conference LLC, Office 504,Abdullah Bin Darwish Bldg. HamdanSalam, St. Junction, AbuDhabi-54210, UAE. Tel.: +971-2491-9888, Email: [email protected] Website: www.menaconference.com/events/7ioc

December 2-6, 2019 ZDRAVOOKHRANENIYE 2019 Moscow,Russia. International Exhibition for Health Care, MedicalEngineering and Pharmaceuticals will be held at Expocentre,Moscow, Russia. For details contact: Expocentre,14,Krasnopresnenskaya nab, Moscow- 123100, Russia. Tel.:+49-211-4560-7734, Email: [email protected]: www.zdravo-expo.ru/en

December 2-3, 2019 Food Microbiology Congress 2019 London,UK. Conference Series Ltd invites all the participants across the

globe to attend Global Summit On Food Microbiology & Nutritionwhich includes prompt keynote presentations, Oral talks, Posterpresentations and Exhibitions. Food Microbiology Congress 2019is a specially designed food and nutritional research Conference.The main theme of this pharma conference is “Advancement in

Food Microbiology and Nutrition” which covers a wide range ofcritically important sessions. It will be held in London, UK. Fordetails contact: Conference Series LLC Ltd., 47, Church fieldRoad, London, W3 6AY, UK. Tel.: +44-203-7690-972, E-mail:[email protected] ; Website: https://www.foodmicrobiology. microbiologyconferences.com/

December 4-5, 2019 UKRAI Pharmaceutical 2019 Kyiv, Ukraine.Ukrainian Pharmaceutical Forum focuses on topics such asreform of healthcare system in Ukraine, regulatory changes in theUkrainian pharmaceutical market, trends in the development ofthe pharmaceutical sector globally and their adaptation inUkraine, investment attractiveness of the pharmaceutical marketin Ukraine, and much more. It will be held at InterContinentalHotel, Kyiv, Ukraine. For details Contact: Adam SmithConferences, 14, Gray’s Inn Road, London, WC1X 8 HN, UnitedKingdom. Tel.: +380-63- 7673207, E-mail: [email protected] Website:www.pharmaukraine.com

December 5-7, 2019 Vietnam Medi Pharm Expo 2019 Hanoi,

Vietnam Vietnam Medi-Pharm Expo is a platform for the world

advanced medical technologies and equipment companies to

access local private and public hospitals and local pharmaceuti-

cal companies which Vietnam hasadvantages to exchange. For

details contact: VINEXADExhibition & Event, 9 Dinh Le, Hanoi,

Vietnam. Tel.: +84-24-3825- 5546, Email: thaituyethuong@

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FORTH COMING EVENTS

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Location Shop Name Contact No.

Agra Satish Book Enterprises 9997877123

Allahabad Friends Book Depot 9451743891

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Page 7: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

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Page 8: USFDA Finds several Violations In Aurobindo Sterile Sun Pharma … · 2019. 12. 12. · Hyderabad:- Dr. Reddy’s Laboratories Ltd.Mob:-09058458612, 09307668480, 09305955262, 09761760618

fudq¡t Lokeh dh vksj ls czts'k dqekj xxZ }kjk izdkf'kr] czts'k dqekj xxZ }kjk eqfær rFkk bEizzs'kal fizafVax ,.M iSfdax fyfefVM uks,Mk] xkSre cq¼ uxj esa eqfær ,oa ch0,u0 eSMhdy dkWEIySDl] cqyUn'kgj ls izdkf'kr lEiknd& czts'k dqekj xxZ

dSfeLVksa dh leL;k;sa lekIr gksxhadSfeLVksa ds lek/ku gsrq iatkc ljdkjLokLF; ea=kh rFkk fçafliy lsDVjh iatkcljdkj o LokLF; foHkkx iatkc ljdkjiQwM ,aM Mªx ,MfefuLVªs'ku rFkk iatkcdSfeLV ,lksfl,'ku dh ,d ehfVax 18-10-2019 dks lqcg ifjokj dY;k.k HkoufLFkr lsDVj& 34 paMhx<+ esa cqykbZ- iatkcdSfeLV ,lksfl,'ku }kjk iatkc ljdkjLokLF; ea=kh o iatkc ljdkj dks viuhvk jgh leL;kvksa ls voxr djok;k Fkk-mlds ckn iatkc ds eq[;ea=kh us LokLF;ea=kh dks iatkc dSfeLV ,lksfl,'ku }kjk

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ZYDUS RECEIVES FINAL APPROVAL FROM THE USFDA FOR CISATRACURIUM BESYLATE INJECTION USP

Ahmedabad, 5 November, 2019:- Zydus Cadila Mob:- 09368696718, 09410210556,

09359503863, 09329621787, 09368010386 has received the final approval from theUSFDA to market Cisatracurium Besylate Injection USP 10 mg (base)/5 mL (2 mg/mL)and 200 mg (base)/20 mL (10 mg/mL) Single-Dose Vials (Preservative-free) (US RLD-Nimbex). This medication is used to relax the muscles. It works by blocking the signalsbetween one’s nerves and one’s muscles. This medicine is given before general anaes-

thesia in preparing for surgery. It will be manufactured at Liva Pharmaceuticals Limited, a wholly-owned subsidiarycompany of Cadila Healthcare Limited. The group now has 275 approvals and has so far filed over 360 ANDAssince the commencement of the filing process in FY 2003-04.

fgekpy esa 13 nokvksa ds lSaiy iQsy] Mªx vyVZ tkjhlksyu] 13 uoEcj (iky)% fgekpy esa cu jgh 13 nokvksa ds lSaiy iQsy gks x, gSa- fiNys10 eghuksa esa fu/kZfjr ekudksa ij iQsy gqbZ nokvksa dh la[;k c<+dj 90 gks xbZ gSa- dsanzh;nok ekud fu;a=kd laxBu (lh-Mh-,l-lh-vks-) us bl ekg dk Mªx vyVZ tkjh fd;k gS-blesa ns'k Hkj esa 36 nokvksa ds lSaiy gq, gSa- lh-Mh-,l-lh-vks- us ns'k Hkj esa 1163 nokvksads lSaiy dh tk¡p dh ftlesa 36 nokvksa ds lSaiy gq, gSa- buesa ls 13 nokvksa dk mRiknufgekpy esa gks jgk gSa- izns'k esa lcls vf/d ch-ch-,u- vkS|ksfxd {ks=k dh 9 nokvksa dslSaiy gq, gSa tcfd ftyk dkaxM+k ds lalkj ij VSjsl ds 2 ftyk mQuk ds gjksyh o ftykfljekSj ds dkykvac m|ksx dk 1&1 lSaiy iQsy gqvk gS- ftu nokvksa ds lSaiy gq, muesagkVZ] ch-ih- 'kqxj cq[kkj] ,aVhck;ksfVd dSfY'k;e ,ythZ bR;kfn dh nokvksa ds lSaiy 'kkfeygSa- Mªx foHkkx us mu lHkh m|ksxksa dks cktkj ls mu nokvksa ds cSap ds LVkWd fjdkWy djusds funsZ'k tkjh dj fn, gSa ftuds lSaiy iQsy gq, gSa- lh-Mh-,l-lh-vks- ls feyh tkudkjhds vuqlkj guqpSe yScksjsVjht ekuiqjk cíh dh ,ftFkksjsfeflu vksjy lLisa'ku 100 ,e-th- dkcSp uacj&,y&1724703] ckW;kstSfufVd Mªx >kM+ektjh dh ,yizksiQsu~ VScysV 400 ,e-th- dkcSp 01019 oh-ts-,- 36] ikdZ iQkekZL;wfVdy dkyqf>aMk utnhd ukudiqj cíh dhekWfDliQykWfDlu vkbZMªWki dk cSp ,y-,p-,y-& 2692] viklekbZ vksdqyj fMokbl dkBkcíh dh Vks;ksVª vkbZ 5 ,l-,y- dk cSp&bZ-Vh-ch- 045] D;ksjVSd fLdu ds;j HkVksyhdykaHkqMM~ dh cSVkfeFkeu fMizksfiz;ksfuV Øhe dk cSp vkj-Mh- 459] th-,u-ch- eSMhdkyScukykx<+ dh (vkbZ-,y-,-oh-bZ&625 VSDysV ) dk cSp &Vh-th- 19&32]th-,e-ch- eSMhdkyScukykx<+ dh flfiQfDle fMlfizftcy VScysV (,l-,-,e-lh-bZ-,iQ&200 Mh-Vh-) dk cSp &Vh-,iQ] 19&88] vycSu gSYFk ds;j dkykvac fljekSj dh yqtksy dk cSp 393] foaXt ck;ksVSdcíh dh dSfY'k;e dkcksZusV VScysV dk cSp & lh-ch-vkj-Vh- 1041] th-,u-ch- eSMhdkyScukykx<+ dh (vuqeksDl&lh-oh-&,y-ch- VScysV ) dk cSp & Vh-th- 19&36 VhVkuSl iQkekZgjksyh mQuk dh esViQksjekbu gkbZMªksDyksjkbM VScysV dk cSp & ,e] 500 ,l-vkj-Vh- 1901]ds;jeSDl iWQkewZys'ku lalkjiqj VSjsl dkaxM+k dh (,fedkds;j 500) dk cSp &lh-,y-vkbZ-]6868 o VSjsl iQkekZL;wfVdy dkaxM+k dh jSeksfizy VScysV dk cSp &,l-Vh-,u- 181394,-dk lSaiy iQsy gks x;k gSa- &galjkt esgrk th] eksñ 9814132529-

Indoco’s Clinical Research Organisation Receives Zero 483s From USFDA

Mumbai:- Indoco Remedies Ltd. Mob:- 09758502980, 09999113560, 07895573946,

07417285763, 09412283241 announced today, that its Clinical Research Organisation,AnaCipher, located at Hyderabad successfully cleared the United States Food and DrugAdministration (USFDA) inspection with zero 483s. The inspection was held from 14thOctober to 18th October, 2019. Commenting on this development, Ms. Aditi KarePanandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for

the fifth time in a row and confirms the capabilities of our team at the CRO for maintaining highest quality stan-dards and excellence in servicing our clients”. The CRO - AnaCipher conducts Bio-Equivalence and Bio-Availability (BA/BE) studies at its facility in Hyderabad and is spread over an area of 30,000 sq. ft. with 98 beds.

Dr. Reddy's Laboratories Announces Launch Of DoxercalciferolInjection In The U.S. Market

Hyderabad:- Dr. Reddy’s Laboratories Ltd. Mob:- 09368696718,

09410210556, 09359503863, 09329621787, 09368010386 along with its sub-sidiaries together referred to as “Dr. Reddy’s”) today announced the launch ofDoxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials, the ther-apeutic generic equivalent of Hectorol® (doxercalciferol) Injection 4 mcg/2 mL(2 mcg/mL) MultipleDose Vials, approved by the U.S. Food and DrugAdministration (USFDA). The Hectorol® Injection 4 mcg/2 mL (2 mcg/mL)

Single-Dose Vials and Multiple-Dose Vials brand and generics had U.S. sales of approximately $138 mil-lion MAT for the most recent twelve months ending in September 2019 according to IQVIA Health*.

Sun Pharma And AstraZeneca Enter Into License Agreement For Novel Oncology Products In China

Mumbai:- Sun Pharmaceutical Industries Ltd. Mob:- 09958124414, 09412480312

“Sun Pharma” and includes its subsidiaries and/or associate companies) today

announced that it has entered into a licensing agreement with AstraZeneca UK Ltd.

(AstraZeneca) to introduce certain novel readyto-use (RTU) infusion oncology prod-

ucts in China. The agreement will help to bring costeffective and quality drugs to

patients in China. As per the terms of the agreement, Sun Pharma will be responsible

for development, regulatory filings and manufacturing the products covered in the

agreement while AstraZeneca will exclusively promote and distribute these products in

China. The initial tenure of the agreement is 10 years from the first commercial sale of

the said products in China. The financial terms of the agreement are confidential. Kal Sundaram, Director

of Corporate Development, Sun Pharma said, “We are pleased to partner with AstraZeneca for commer-

cialisation of our select novel oncology products in China. AstraZeneca’s leadership position will help us to

make our products available to patients and doctors in China. We see a great potential to introduce our

speciality and generics products in the growing China market and this licensing agreement is another pos-

itive step in that direction.” The agreement will be announced today at the China International Import Expo

(CIIE) in Shanghai. CIIE is a world-class expo that is organised by Ministry of Commerce of the People's

Republic of China. It is an open cooperation platform to invite countries into China to showcase their

national image and engage in international trade.

Glenmark Pharma Gets USFDA Nod For Diabetes Management DrugNEW DELHI:- Glenmark Pharmaceuticals Mob:- 09999442531, 09319755551

on Tuesday said it has received final nod from the US health regulator for met-formin hydrochloride tablets used in the management of type-two diabetes."Glenmark Pharmaceuticals Inc, USA, has been granted final approval by theUnited States Food & Drug Administration (USFDA) for metformin hydrochlorideextended release tablets USP, 500 mg and 1000 mg, the generic version of

Glumetza extended release tablets, 500 mg and 1,000 mg, of Salix Pharmaceuticals Inc," the drug makersaid in a filing to BSE. Citing IQVIA sales data for the 12-month period ending September 2019, the com-pany said that Glumetza tablets, 500 mg and 1,000 mg market achieved annual sales of approximatelyUSD 226.7 million. Glenmark's current portfolio consists of 164 products authorised for distribution in theUS marketplace and 44 abbreviated new drug applications pending approval with the USFDA.

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