Diclofenac Potassium

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 6 CEP/COS, 4 EU WC, 1 KDMF, 6 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

154 FDF Dossiers, 27 FDA Orange Book, 61 Europe, 5 Canada, 8 South Africa, 53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 5 Rochem International Inc, 18 SPI Pharma, 10 DKSH, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 2 Kirsch Pharma, 4 ACG Worldwide, 10 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 25 BASF, 1 Bioplus Life Sciences, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 39 Direct Compression, 34 Disintegrants & Superdisintegrants, 33 Granulation, 31 Thickeners and Stabilizers, 30 Taste Masking, 26 Solubilizers, 24 Parenteral, 22 Controlled & Modified Release, 20 Film Formers & Plasticizers, 20 Chewable & Orodispersible Aids, 17 Topical, 15 Lubricants & Glidants, 15 Co-Processed Excipients, 9 Empty Capsules, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

18 US Medicaid Prescriptions, 1 Regulatory FDF Prices

MARKET PLACE

22 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 22202 / DOSAGE - CAPSULE;ORAL - 25MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
diclofenac potassium(UNII: L4D5UA6CB4) (diclofenac - UNII:144O8QL0L1)	diclofenac potassium	25mg

Inactive Ingredients

Ingredient Name	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Strides Pharma Science Limited	Lake Erie Medical DBA Quality Care Products	PD-Rx Pharmaceuticals, Inc.
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
HYDROCHLORIC ACID(QTT17582CB)
ISOPROPYL ALCOHOL(ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
MINERAL OIL(T5L8T28FGP)
NONCRYSTALLIZING SORBITOL SOLUTION(9E0S3UM200)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SORBITOL(506T60A25R)

Setid 61420046 B04b 4532 A21d 65986966f681 Applno 22202 Form Capsule Oral Dosage 25mg - Drug Product Composition: Diclofenac Potassium