5-aminosalicylic acid, Mesalazine, Asacol, Pentasa, Canasa, Mesalamine

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ACTIVE PHARMA INGREDIENTS

113 API Suppliers, 53 USDMF, 35 CEP/COS, 13 JDMF, 16 EU WC, 10 KDMF, 38 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

574 FDF Dossiers, 45 FDA Orange Book, 398 Europe, 18 Canada, 46 Australia, 17 South Africa, 50 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- 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG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

8 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 14 DKSH, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 31 BASF, 1 CD Formulation, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 12 Ideal Cures, 1 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

65 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 42 Thickeners and Stabilizers, 39 Controlled & Modified Release, 28 Solubilizers, 28 Disintegrants & Superdisintegrants, 25 Granulation, 23 Direct Compression, 17 Lubricants & Glidants, 16 Topical, 14 Film Formers & Plasticizers, 12 Rheology Modifiers, 11 Taste Masking, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Co-Processed Excipients, 5 Emulsifying Agents, 5 Parenteral, 5 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 71 News #PharmaBuzz

GLOBAL SALES INFORMATION

41 US Medicaid Prescriptions, 155 Regulatory FDF Prices, 37 Annual Reports

MARKET PLACE

24 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 22 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20049 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 500MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESALAMINE(UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	500mg \| 250mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Cardinal Health	Prasco Laboratories	REMEDYREPACK INC.
CASTOR OIL(D5340Y2I9G)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
D&C YELLOW NO. 10(35SW5USQ3G)
DIACETYLATED MONOGLYCERIDES(5Z17386USF)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
POTASSIUM HYDROXIDE(WZH3C48M4T)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WHITE WAX(7G1J5DA97F)

Drug Product Composition: 5-aminosalicylic acid, Mesalazine, Asacol, Pentasa, Canasa, Mesalamine