Simvastatin (Zocor)

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ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 37 USDMF, 42 CEP/COS, 7 JDMF, 7 EU WC, 45 KDMF, 12 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1150 FDF Dossiers, 140 FDA Orange Book, 729 Europe, 70 Canada, 52 Australia, 88 South Africa, 71 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 5 SPI Pharma, 9 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 26 BASF, 2 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 35 Thickeners and Stabilizers, 31 Direct Compression, 29 Granulation, 24 Controlled & Modified Release, 20 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 19 Solubilizers, 17 Film Formers & Plasticizers, 16 Topical, 13 Taste Masking, 10 Parenteral, 10 Co-Processed Excipients, 10 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 50 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 347 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

22 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents

16 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 9 Others

ANALYTICAL

7 BioAnalytical Methods

7 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 206679 / DOSAGE - SUSPENSION;ORAL - 20MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Simvastatin(UNII: AGG2FN16EV) (Simvastatin - UNII:AGG2FN16EV)	Simvastatin	20mg in 5

Inactive Ingredients

Ingredient Name	Ayurax
ACESULFAME POTASSIUM(23OV73Q5G9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
DIMETHICONE(92RU3N3Y1O)
ETHYLPARABEN(14255EXE39)
MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
WATER(059QF0KO0R)

Setid 791bd873 4a72 414b 96a2 7798bc00fe85 Applno 206679 Form Suspension Oral Dosage 20mg 5ml - Drug Product Composition: Simvastatin (Zocor)