apothecon · pharmaceuticals pvt. ltd. a caring company. . . founded in 2007 350+ employees...

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APOTHECON Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche APIs & Formulations Drug development expertise for complex moleclues Commercial supplies across the globe Upcoming API facility with capacity upto 450 TPA Business associate of Navinta USA & Waymade UK 15+ DMF & ANDA filed 15+ molecules under development Fast Facts

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Page 1: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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

Page 2: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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

Page 3: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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)

Page 4: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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

Page 5: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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#

Page 6: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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^

Page 7: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

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 :

Page 8: APOTHECON · Pharmaceuticals Pvt. Ltd. A Caring Company. . . Founded In 2007 350+ Employees Manufacturing Niche ... Generic APIs High Potent APIs API Custom Manufacturing We manufacture

CONTACT US :

[email protected]

+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