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TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GRANULES, EXTENDED RELEASE;ORAL - 1GM, GRANULES, EXTENDED RELEASE;ORAL - 500MG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 - 216018 / DOSAGE - GRANULES, EXTENDED RELEASE;ORAL - 500MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANOLAZINE(UNII: A6IEZ5M406) (RANOLAZINE - UNII:A6IEZ5M406)	RANOLAZINE	500mg \| 1000mg

Inactive Ingredients

Ingredient Name	SUN PHARMACEUTICAL INDUSTRIES, INC.
DIBUTYL SEBACATE(4W5IH7FLNY)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
TALC(7SEV7J4R1U)

Setid Dd9f81e4 50da 4551 Aed5 559d304df42e Applno 216018 Form Granules Extended Release Oral Dosage 500mg - Drug Product Composition: Ranolazine (USAN/INN)