Hydralazine hydrochloride, Apresoline

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 24 USDMF, 5 CEP/COS, 1 JDMF, 7 EU WC, 14 NDC API, 8 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

190 FDF Dossiers, 171 FDA Orange Book, 3 Europe, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 37.5MG;20MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 17 SPI Pharma, 5 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 2 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 15 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 33 Direct Compression, 24 Thickeners and Stabilizers, 22 Granulation, 21 Disintegrants & Superdisintegrants, 19 Solubilizers, 19 Controlled & Modified Release, 18 Taste Masking, 18 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 16 Topical, 15 Co-Processed Excipients, 12 Film Formers & Plasticizers, 12 Parenteral, 9 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents

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18 News #PharmaBuzz

GLOBAL SALES INFORMATION

15 US Medicaid Prescriptions, 3 Regulatory FDF Prices

MARKET PLACE

8 APIs, 1 FDF Dossiers, 1 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 EDQM, 1 Others

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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: Hydralazine hydrochloride, Apresoline