ALISKIREN FUMARATE [WHO-DD]

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 4 USDMF, 1 EU WC, 3 NDC API, 3 Listed Suppliers

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

49 FDF Dossiers, 20 FDA Orange Book, 29 Europe

DRUG PRODUCT COMPOSITIONS

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EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 1 Cerata Pharmaceuticals LLP, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 22 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

38 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 19 Disintegrants & Superdisintegrants, 18 Direct Compression, 18 Thickeners and Stabilizers, 17 Granulation, 13 Solubilizers, 12 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Topical, 8 Chewable & Orodispersible Aids, 7 Film Formers & Plasticizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Emulsifying Agents, 2 Coloring Agents, 2 Rheology Modifiers, 2 Parenteral

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 1 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 10 Health Canada Patents

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USFDA APPLICATION NUMBER - 21985 / DOSAGE - TABLET;ORAL - EQ 150MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)	ALISKIREN	300mg \| 150mg

Inactive Ingredients

Ingredient Name	Endo USA, Inc.	A-S Medication Solutions	Avera McKennan Hospital	Novartis Pharmaceuticals Corporation	Prasco Laboratories
CALCIUM STEARATE(776XM7047L)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

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Setid 833c7a0b 5f64 4363 94d5 9a179049113a Applno 21985 Form Tablet Oral Dosage Eq 150mg Base - Drug Product Composition: ALISKIREN FUMARATE [WHO-DD]