Prestwick3_000516

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 31 USDMF, 12 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 8 NDC API, 11 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers, 37 FDA Orange Book, 42 Europe, 4 Canada, 2 South Africa, 6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 4 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 36 Direct Compression, 31 Controlled & Modified Release, 27 Thickeners and Stabilizers, 26 Solubilizers, 24 Granulation, 21 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 18 Film Formers & Plasticizers, 18 Co-Processed Excipients, 18 Topical, 16 Parenteral, 10 Taste Masking, 9 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 7 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 52 Finished Drug Prices

MARKET PLACE

5 APIs

5 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 7 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21316 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOVASTATIN(UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)	LOVASTATIN	60mg \| 40mg \| 20mg

Inactive Ingredients

Ingredient Name	Covis Pharma US, Inc	Shionogi Inc.
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
CANDELILLA WAX(WL0328HX19)
CELLULOSE ACETATE(3J2P07GVB6)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM LAURYL SULFATE(368GB5141J)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Prestwick3_000516