Prestwick3_000478

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 16 USDMF, 9 CEP/COS, 1 JDMF, 4 EU WC, 17 KDMF, 6 NDC API, 10 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem, 5 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 34 Direct Compression, 29 Solubilizers, 29 Controlled & Modified Release, 24 Thickeners and Stabilizers, 19 Granulation, 18 Topical, 18 Co-Processed Excipients, 16 Film Formers & Plasticizers, 15 Disintegrants & Superdisintegrants, 13 Parenteral, 13 Lubricants & Glidants, 9 Emulsifying Agents, 8 API Stability Enhancers, 8 Chewable & Orodispersible Aids, 7 Taste Masking, 5 Empty Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

75 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

6 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 19834 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **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
FELODIPINE(UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)	FELODIPINE	10mg \| 5mg \| 2.5mg

Inactive Ingredients

Ingredient Name	AstraZeneca Pharmaceuticals LP	Bryant Ranch Prepack
ALCOHOL(3K9958V90M)
ALUMINUM SILICATE(T1FAD4SS2M)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSES(3NXW29V3WO)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONES(FZ989GH94E)
PROPYL GALLATE(8D4SNN7V92)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Prestwick3_000478