Irbesartan

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 41 USDMF, 29 CEP/COS, 14 JDMF, 24 EU WC, 28 KDMF, 15 NDC API, 45 Listed Suppliers, $ API Reference Price

INTERMEDIATES

15 Intermediates Suppliers

15 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

975 FDF Dossiers, 118 FDA Orange Book, 585 Europe, 59 Canada, 60 Australia, 34 South Africa, 119 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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 17 SPI Pharma, 2 Seqens, 4 DKSH, 3 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 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

92 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 45 Direct Compression, 34 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 30 Lubricants & Glidants, 28 Granulation, 28 Solubilizers, 28 Thickeners and Stabilizers, 23 Parenteral, 22 Topical, 22 Co-Processed Excipients, 17 Taste Masking, 17 Chewable & Orodispersible Aids, 17 Film Formers & Plasticizers, 11 Emulsifying Agents, 8 API Stability Enhancers, 6 Rheology Modifiers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 96 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 5 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20758 / DOSAGE - TABLET;ORAL - 12.5MG;150MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydrochlorothiazide(UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)	hydrochlorothiazide	12.5mg \| 12.5mg
irbesartan(UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)	irbesartan	300mg \| 150mg

Inactive Ingredients

Ingredient Name	Apotex Corp.	NuCare Pharmaceuticals, Inc.	REMEDYREPACK INC.	Cardinal Health	Legacy Pharmaceutical Packaging	Mylan Pharmaceuticals Inc.	AvKARE, Inc.	Proficient Rx LP	Qualitest Pharmaceuticals	Unichem Pharmaceuticals (USA), Inc.	Lupin Pharmaceuticals, Inc.	Rising Pharmaceuticals, Inc.
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
ferric oxide red(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 3000(SA1B764746)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K25(K0KQV10C35)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
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

94 API Suppliers

41 USDMF

29 CEP/COS

14 JDMF

24 EU WC

28 KDMF

15 NDC API

45 Listed Suppliers

$ API Reference Price

INTERMEDIATES

15 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

975 FDF Dossiers

118 FDA Orange Book

585 Europe

59 Canada

60 Australia

34 South Africa

119 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

17 SPI Pharma

2 Seqens

4 DKSH

3 Jai Radhe Sales

7 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

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

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