ISD

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 3 CEP/COS, 5 JDMF, 7 KDMF, 3 NDC API, 7 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers, 65 FDA Orange Book, 21 Europe, 4 Canada, 2 Australia, 13 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 7 DKSH, 1 Jai Radhe Sales, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 31 Direct Compression, 27 Thickeners and Stabilizers, 27 Controlled & Modified Release, 19 Granulation, 19 Disintegrants & Superdisintegrants, 17 Lubricants & Glidants, 16 Co-Processed Excipients, 15 Solubilizers, 13 Film Formers & Plasticizers, 11 Topical, 10 Taste Masking, 9 Parenteral, 9 Empty Capsules, 7 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 32 Finished Drug Prices

MARKET PLACE

10 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP

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USFDA APPLICATION NUMBER - 20727 / DOSAGE - TABLET;ORAL - 37.5MG;20MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydralazine hydrochloride(UNII: FD171B778Y) (Hydralazine - UNII:26NAK24LS8)	Hydralazine hydrochloride	37.5mg
Isosorbide dinitrate(UNII: IA7306519N) (Isosorbide dinitrate - UNII:IA7306519N)	Isosorbide dinitrate	20mg

Inactive Ingredients

Ingredient Name	Arbor Pharmaceuticals
aluminum oxide(LMI26O6933)
anhydrous lactose(3SY5LH9PMK)
FD&C Yellow No. 6(H77VEI93A8)
hypromellose, unspecified(3NXW29V3WO)
magnesium stearate(70097M6I30)
microcrystalline cellulose(OP1R32D61U)
polyethylene glycol, unspecified(3WJQ0SDW1A)
polysorbate 80(6OZP39ZG8H)
silicon dioxide(ETJ7Z6XBU4)
sodium starch glycolate type a potato(5856J3G2A2)
titanium dioxide(15FIX9V2JP)

Drug Product Composition: ISD

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers

15 USDMF

3 CEP/COS

5 JDMF

7 KDMF

3 NDC API

7 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers

65 FDA Orange Book

21 Europe

4 Canada

2 Australia

13 South Africa

10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG

CAPSULE, EXTENDED RELEASE;ORAL - 40MG

TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

2 Seqens

7 DKSH

1 Jai Radhe Sales

11 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

6 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

13 BASF

11 Corel Pharma Chem

6 DFE Pharma

1 Finar

9 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

19 Roquette

13 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

3 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders

47 Coating Systems & Additives

31 Direct Compression

27 Thickeners and Stabilizers

27 Controlled & Modified Release

19 Granulation

19 Disintegrants & Superdisintegrants

17 Lubricants & Glidants

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons