Ranolazine (USAN/INN)

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

57 API Suppliers, 27 USDMF, 15 EU WC, 2 KDMF, 22 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

151 FDF Dossiers, 58 FDA Orange Book, 68 Europe, 2 Canada, 3 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GRANULES, EXTENDED RELEASE;ORAL - 1GM, GRANULES, EXTENDED RELEASE;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 SPI Pharma, 4 DKSH, 3 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Clariant, 13 Corel Pharma Chem, 4 DFE Pharma, 10 Gangwal Chemicals, 9 Ideal Cures, 21 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 26 Controlled & Modified Release, 14 Solubilizers, 14 Direct Compression, 14 Thickeners and Stabilizers, 13 Granulation, 12 Film Formers & Plasticizers, 12 Lubricants & Glidants, 10 Parenteral, 9 Co-Processed Excipients, 7 Topical, 6 Disintegrants & Superdisintegrants, 6 Taste Masking, 6 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Chewable & Orodispersible Aids

DIGITAL CONTENT

27 News #PharmaBuzz

27 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 18 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

18 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

REF. STANDARDS & IMPURITIES

10 Others

10 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21526 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ranolazine(UNII: A6IEZ5M406) (ranolazine - UNII:A6IEZ5M406)	ranolazine	500mg

Inactive Ingredients

Ingredient Name	Cardinal Health
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
ferric oxide yellow(EX438O2MRT)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
hypromelloses(3NXW29V3WO)
magnesium stearate(70097M6I30)
methacrylic acid - Ethyl Acrylate Copolymer (1:1) Type A(NX76LV5T8J)
polyethylene glycol 3350(G2M7P15E5P)
polyethylene glycol 400(B697894SGQ)
polyvinyl alcohol(532B59J990)
sodium hydroxide(55X04QC32I)
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
water(059QF0KO0R)

Setid Ac529edf 5634 49fa 8db5 Ba3a39763161 Applno 21526 Form Tablet Extended Release Oral Dosage 1gm - Drug Product Composition: Ranolazine (USAN/INN)