apothecon · pharmaceuticals pvt. ltd. a caring company. . . founded in 2007 350+ employees...
TRANSCRIPT
APOTHECONPharmaceuticals Pvt. Ltd.A Caring Company. . .
Founded In 2007 350+ Employees Manufacturing NicheAPIs & Formulations
Drug development expertisefor complex moleclues
Commercial suppliesacross the globe
Upcoming API facilitywith capacity upto 450 TPA
Business associate ofNavinta USA & Waymade UK
15+ DMF &ANDA filed
15+ moleculesunder development
Fast
Fac
ts
Scanning all phases from R&D to commercialization, our network of C-GMP facilities with adaptable volumes, state-of-the-art technology & stringent quality systems provide flexible solutions to overcome challenges often
associated with outsourcing .
R&DCAPABILITIES
65+ R&D Scientists
Structural elucidation fordrug substance & its impurities
14 Patents forinnovative work
Expertise in diversetherapeutic areas
Prowess incomplex chemistry
Non-Infringing & cost effectivedevelopment of generics
Labs equipped withsophisticated instruments
Analytical method development,validation & transfer
1,510 sq.m ofdedicated R&D area
RESEARCH AND DEVELOPMENT
SEXU
AL
DYSF
UNCT
ION
TADALAFIL
Erectile Dysfunction
DAPOXETINEPrematureEjaculation
FERUMOXYTOLIron Deficiency
Anemia Iron DeficiencyAnemia
FERRIC CARBOXYMALTOSE
LINAGLIPTINType 2 Diabetes HIV Infection
MARAVIROCNon Small Cell Lung
Carcinoma
CRIZOTINIB
Gauchers DiseaseMIGLUSTAT
High BP/Angina
NICARDIPINE(Oral)Oral Absorbtion
Promoter
SALCAPROZIC ACID
FLUNARIZINEMigraine
ASENAPINEBipolar Disorder
PREGABALINNeuropathic Pain
TRIAZOLAM PREGABALIN
CNS
HA
EMAT
INIC
NIC
HE
API
s
Drug product
Drug Substance
DEVELOPMENT PIPELINE
We have GLP compliant laboratory equipped with ICPMS & have capabilities to provide elemental impurities testing services including method development and val idat ion as per USP & ICHQ3D requirements.
ICPMS TESTING(Inductively Coupled Plasma- Mass spectrometry)
APIs No matter where you are in niche APIs on the development path from R&D to Commercialization, your project will benefit from Apothecon's breath of manufacturing capabilities.
High Potent APIs API Custom ManufacturingGeneric APIs
We manufacture & supply over 26 APIs for various indications. By using our technical expertise, we work well in advance of drug patent expiration to formulate non-infringing processes & DMFs for our APIs.
We specialize in producing high potent oncology APIs in separate facility with dedicated manpower. Using containment safety systems, & the lowest occupational exposure limits, we take care of product quality as well as health & safety of our personnel.
With our new large volume API facililty coming up, we have linked together the best of capabilities to support your need for high volume API products.
Saving costs and timelines of developing APIs into finished products, our formulation portfolio offers ready FDFs targeting an array of niche therapeutic categories along with CRAMS.
Generic Oral Solids Generic Parenterals Topical Semi solidFormulation
Expanding our capabilites to manufacture topical semi solid formulation as a part of our expansion plan.
•Facility accredited from MHRA and USFDA for manufacturing of Oral Solid Drug product with batch size ranging from 10 to 300 Kg.
Developed, manufactured and commercialized 4 oral solid drug products for US & EU market.
•
•
14+ injectable drug products Supplying generic Injectable products from India, US & EU facilities to meet stringent regulatory standards.
••
FORMULATIONS
ACTIVE PHARMACEUTICAL INGREDIENTSSN.
1.
PRODUCT NAME CAS NO. DMF NO.
27272
2976630492
3015219084
030905
19683
1374784-02-76055-19-2
3223-07-2154-93-8
148-82-3
132112-35-784057-95-4
71550-12-4
38260-01-4
7554-65-6123799-93-9
Bendamustine HydrochlorideCyclophosphamide Monohydrate ^#
Melphalan HydrochlorideCarmustine*
Melphalan #
Ropivacaine HydrochlorideRopivacaine
Polyallylamine Hydrochloride
Trientine Hydrochloride USP^
Fomepizole ^
Fomepizole Sulfate ^
NOTE : • All products marked * are unavailable for BOTH, the US & Europe market.• All products marked ^ are unavailable for ONLY the US market.• All products marked # are under validation & will be available shortly for commercial supply.• Patented products are available for R&D purposes only as permitted under 35 U.S.C. Section 271 (e) (I).
ANTI-CANCER
2. RARE DRUGS
3. PHOSPHATE BINDERS
4. HAEMATOLOGICALS
5. CARDIOVASCULAR
6. ANTI-RHEUMATIC
7. CNS
8. ANESTHETICS
9. INTERMEDIATE FOR SEVELAMER GROUP
2740527908
845273-93-0152751-57-012134-57-5
Sevelamer CarbonateSevelamer HydrochlorideSucroferric Oxyhydroxide*#
030910
18261
84-80-0
8047-67-4
34089-81-1
141396-28-3
Phytonadione (Vitamin K1)^
Iron Sucrose Complex USP
Sodium Ferric Gluconate Complex*#
Argatroban USP^
02432119773
031746
33106
3213633105
304-20-1
63-92-3
54527-84-3
37296-80-3182815-44-7
Colestipol Hydrochloride*#Colesevelam Hydrochloride*Hydralazine Hydrochloride USPNicardipine Hydrochloride USP
Phenoxybenzamine HCI USP
52-67-5Penicillamine^
132-17-1265721-04-8
Benztropine Mesylate USPFosaprepitant Dimeglumine
85650-56-2Asenapine Maleate#
FORMULATIONS
Injectable
Capsule
Lozenges
250 mg
2 mg/ml
Bendamustine HydrochlorideMonohydrate #^
Carmustine *
100 mg/ml
100 mg/vial
Injectable
Injectable
Injectable
Injectable
0.5 gm/vial, 1 gm/vial2 gm/vial
50 mg/vial
Cyclophosphamide Monohydrate *#(sterile powder)
Melphalan Hydrochloride #
2 mg & 4 mgNicotine Polacrilex *
Penicillamine^#
Benztropine Mesylate USP ^#
• Patented products are available for R&D purposes only as permitted under 35 U.S.C. Section 271 (e) (I).
NOTE : • All products marked * are unavailable for BOTH, the US & Europe market.• All products marked ^ are unavailable for ONLY the US market.• All products marked # are under validation & will be available shortly for commercial supply.
SN.
1.
PRODUCT NAME & CATEGORY STRENGTH DOSAGE
ANTI-CANCER
2. RARE DRUGS
3. PHOSPHATE BINDERS
4. HAEMATOLOGICALS
5. CARDIOVASCULAR
6. ANTI-RHEUMATIC
7. CNS
8. ANESTHETICS
9. SMOKING DETTERENTS
Injectable
Capsule250 mg
1 gm/mlFomepizole^
Trientine Hydrochloride USP*
Injectable5 mg/mlFomepizole Sulphate^
Tablet
Tablet
400 & 800 mg
400 & 800 mg
Sevelamer Carbonate *
Sevelamer Hydrochloride *
Injectable
Injectable
Injectable
Tablet5 mg
250 mg/2.5 ml
2.5 ml & 5 ml
Phytonadione (Vitamin K1)*
10 mg/mlPhytonadione (Vitamin K1) *# (Emulsion)
Iron Sucrose Complex USP *
Argatroban USP ^#
Injectable
Injectable
Tablet625 mg
20 mg/ml
Colesevelam Hydrochloride *#
Hydralazine Hydrochloride USP#
2.5mg/mlNicardipine Hydrochloride USP*#
InjectableRopivacaine Hydrochloride # 10mg/ml (1.0%),5mg/ml (0.5%)
Injectable150 mg/vialFosaprepitant Dimeglumine^
Why PartnerWith Us?
• Strong operational infrastructure & expertise in what we do.
• Sustained growth trajectory.
• Competitive prices & high quality products.
• Uncompromising standards & business ethics.
• One stop for all key products in diverse categories.
Successfully Inspected By :
CONTACT US :
+91-2662-244212+91-9099007601
www.apotheconpharma.com
Plot No. 1134 to 1137, 1138-A & B, 1143-A & B, 1144-A & B,Padra-Jambusar Highway, At & Post : Dabhasa - 391440,Ta : Padra, Dist : Vadodara, Gujarat, India