Prestwick2_001069

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

93 API Suppliers, 53 USDMF, 33 CEP/COS, 13 JDMF, 13 EU WC, 10 KDMF, 45 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

6 API Suppliers

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

440 FDF Dossiers, 41 FDA Orange Book, 293 Europe, 17 Canada, 40 Australia, 13 South Africa, 36 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML, CAPSULE, EXTENDED RELEASE;ORAL - 250MG, CAPSULE, EXTENDED RELEASE;ORAL - 500MG, CAPSULE, DELAYED RELEASE;ORAL - 400MG, SUPPOSITORY;RECTAL - 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

3 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 11 DKSH, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Finar, 9 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 30 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 13 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

67 Coating Systems & Additives, 60 Fillers, Diluents & Binders, 43 Controlled & Modified Release, 37 Thickeners and Stabilizers, 32 Direct Compression, 29 Disintegrants & Superdisintegrants, 26 Solubilizers, 22 Granulation, 18 Lubricants & Glidants, 15 Topical, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 11 Taste Masking, 9 Empty Capsules, 8 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 7 Parenteral, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 66 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 200 Finished Drug Prices, 35 Annual Reports

MARKET PLACE

22 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 13 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 204412 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 400MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESALAMINE(UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	400mg

Inactive Ingredients

Ingredient Name	Allergan, Inc.
DIBUTYL SEBACATE(4W5IH7FLNY)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONE(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TALC(7SEV7J4R1U)

Drug Product Composition: Prestwick2_001069