Rosuvastatin Calcium

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ACTIVE PHARMA INGREDIENTS

129 API Suppliers, 52 USDMF, 46 CEP/COS, 14 JDMF, 30 EU WC, 84 KDMF, 23 NDC API, 58 Listed Suppliers, $ API Reference Price

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

420 FDF Dossiers, 120 FDA Orange Book, 137 Europe, 88 Canada, 25 South Africa, 50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 10MG BASE, CAPSULE;ORAL - EQ 20MG BASE, CAPSULE;ORAL - EQ 40MG BASE, CAPSULE;ORAL - EQ 5MG BASE, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 7 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 11 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 21 BASF, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 43 Direct Compression, 29 Controlled & Modified Release, 25 Lubricants & Glidants, 25 Disintegrants & Superdisintegrants, 23 Granulation, 23 Thickeners and Stabilizers, 19 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 17 Taste Masking, 13 Topical, 12 Film Formers & Plasticizers, 11 Parenteral, 11 Solubilizers, 8 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents, 2 Rheology Modifiers

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices, 20 Annual Reports

MARKET PLACE

30 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

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2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 208647 / DOSAGE - CAPSULE;ORAL - EQ 40MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	40mg \| 20mg \| 10mg \| 5mg

Inactive Ingredients

Ingredient Name	Sun Pharmaceutical Industries, Inc.
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CROSPOVIDONE(2S7830E561)
D&C RED NO. 28(767IP0Y5NH)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MAGNESIUM OXIDE(3A3U0GI71G)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM LAURYL SULFATE(368GB5141J)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Rosuvastatin Calcium