Tox21_300265

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 21 USDMF, 16 CEP/COS, 13 JDMF, 7 EU WC, 20 KDMF, 27 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

459 FDF Dossiers, 99 FDA Orange Book, 100 Europe, 37 Canada, 62 South Africa, 161 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2%, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 11 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 12 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 48 BASF, 1 BioSpectra, 18 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 14 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 15 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 72 Coating Systems & Additives, 50 Direct Compression, 50 Controlled & Modified Release, 47 Solubilizers, 41 Disintegrants & Superdisintegrants, 39 Topical, 38 Thickeners and Stabilizers, 35 Granulation, 29 Parenteral, 25 Lubricants & Glidants, 24 Film Formers & Plasticizers, 23 Co-Processed Excipients, 20 Taste Masking, 19 Emulsifying Agents, 10 Chewable & Orodispersible Aids, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

96 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

60 APIs, 23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20607 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICLOFENAC SODIUM(UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	50mg
MISOPROSTOL(UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)	MISOPROSTOL	200ug

Inactive Ingredients

Ingredient Name	Putney, Inc.	A-S Medication Solutions	Actavis Pharma, Inc.	American Health Packaging	BluePoint Laboratories	Dash Pharmaceuticals LLC	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Preferred Pharmaceuticals, Inc.	Bryant Ranch Prepack	PD-Rx Pharmaceuticals, Inc.
ALCOHOL(3K9958V90M)
cellulose, microcrystalline(OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
GLYCINE(TE7660XO1C)
GLYCOFUROL(YZC5LZ8BUB)
HYDROGENATED CASTOR OIL(ZF94AP8MEY)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
lactose(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MEGLUMINE(6HG8UB2MUY)
methacrylic acid - ethyl acrylate copolymer (1:1) type a(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 188(LQA7B6G8JG)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
sodium starch glycolate type a potato(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
talc(7SEV7J4R1U)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)

Drug Product Composition: Tox21_300265

Tox21_300265

Tox21_300265

ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

21 USDMF

16 CEP/COS

13 JDMF

7 EU WC

20 KDMF

27 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

459 FDF Dossiers

99 FDA Orange Book

100 Europe

37 Canada

62 South Africa

161 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;TOPICAL - 2%

TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG

TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG

SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TOPICAL - 1%

SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

1 Rochem International Inc

11 SPI Pharma

2 Seqens

5 DKSH

2 Jai Radhe Sales

12 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

12 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

15 Actylis

3 Aeon Procare

4 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

48 BASF

1 BioSpectra

18 Corel Pharma Chem

7 DFE Pharma

3 Doshion Polyscience

3 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

14 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

38 Kerry

3 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

16 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;TOPICAL - 1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TOPICAL - 3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons