Irbesartan

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ACTIVE PHARMA INGREDIENTS

93 API Suppliers, 41 USDMF, 30 CEP/COS, 14 JDMF, 24 EU WC, 27 KDMF, 15 NDC API, 45 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

14 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

968 FDF Dossiers, 118 FDA Orange Book, 585 Europe, 59 Canada, 58 Australia, 28 South Africa, 120 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG, TABLET;ORAL - 300MG, TABLET;ORAL - 75MG, TABLET;ORAL - 12.5MG;150MG, TABLET;ORAL - 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 4 DKSH, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 7 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 27 BASF, 3 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 6 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 36 Disintegrants & Superdisintegrants, 35 Direct Compression, 31 Controlled & Modified Release, 29 Solubilizers, 29 Lubricants & Glidants, 28 Granulation, 27 Thickeners and Stabilizers, 23 Parenteral, 22 Topical, 18 Taste Masking, 18 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 17 Film Formers & Plasticizers, 11 Emulsifying Agents, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 6 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

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2 US Medicaid Prescriptions, 468 Finished Drug Prices, 22 Annual Reports

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13 APIs, 5 FDF Dossiers

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6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

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2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20757 / DOSAGE - TABLET;ORAL - 75MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
irbesartan(UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)	irbesartan	300mg \| 150mg

Inactive Ingredients

Ingredient Name	Apotex Corp.	West-Ward Pharmaceuticals Corp.	American Health Packaging	REMEDYREPACK INC.	Unit Dose Services	Ajanta Pharma Limited	Carilion Materials Management	Lake Erie Medical DBA Quality Care Products LLC	Legacy Pharmaceutical Packaging, LLC	Teva Pharmaceuticals USA, Inc.	A-S Medication Solutions	Alembic Pharmaceuticals Inc.	Bryant Ranch Prepack	Cardinal Health	Golden State Medical Supply	Proficient Rx LP	Unichem Pharmaceuticals (USA), Inc.	Westminster Pharmaceuticals, LLC	Lupin Pharmaceuticals, Inc.	Rising Pharmaceuticals, Inc.
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM STEARATE(776XM7047L)
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
lactose(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
poloxamer 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 3000(SA1B764746)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Irbesartan

Irbesartan

Irbesartan

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

93 API Suppliers

41 USDMF

30 CEP/COS

14 JDMF

24 EU WC

27 KDMF

15 NDC API

45 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

968 FDF Dossiers

118 FDA Orange Book

585 Europe

59 Canada

58 Australia

28 South Africa

120 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG

TABLET;ORAL - 300MG

TABLET;ORAL - 75MG

TABLET;ORAL - 12.5MG;150MG

TABLET;ORAL - 12.5MG;300MG

TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

18 SPI Pharma

2 Seqens

4 DKSH

7 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

7 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 ACG Worldwide

5 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

27 BASF

3 Clariant

10 Corel Pharma Chem

7 DFE Pharma

2 Finar

12 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

2 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

6 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

14 Seppic

8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

TABLET;ORAL - 12.5MG;75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 25MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons