Prestwick2_001069

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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- 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG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

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USFDA APPLICATION NUMBER - 22000 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 1.2GM

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESALAMINE(UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	1.2g

Inactive Ingredients

Ingredient Name	Mylan Pharmaceuticals Inc.	KAISER FOUNDATION HOSPITALS	Avera McKennan Hospital	Golden State Medical Supply, Inc.	Sun Pharmaceutical Industries, Inc.
AMMONIA(5138Q19F1X)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CARBOXYMETHYLCELLULOSE(05JZI7B19X)
CARNAUBA WAX(R12CBM0EIZ)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Prestwick2_001069