Asacol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

113 API Suppliers, 53 USDMF, 35 CEP/COS, 13 JDMF, 16 EU WC, 10 KDMF, 39 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

576 FDF Dossiers, 45 FDA Orange Book, 398 Europe, 18 Canada, 48 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- 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG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, 72 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

25 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

$ Xls

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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)

Setid 07e5ac9c A5b2 42dc 84fa 963dbc51ba21 Applno 22000 Form Tablet Delayed Release Oral Dosage 1 2gm - Drug Product Composition: Asacol

Asacol

Asacol

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

113 API Suppliers

53 USDMF

35 CEP/COS

13 JDMF

16 EU WC

10 KDMF

39 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

576 FDF Dossiers

45 FDA Orange Book

398 Europe

18 Canada

48 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

TABLET, DELAYED RELEASE;ORAL - 800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons