Alpharma Brand of Propafenone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 5 EU WC, 2 KDMF, 15 NDC API, 7 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

103 FDF Dossiers, 53 FDA Orange Book, 30 Europe, 10 Canada, 2 South Africa, 8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 225MG, CAPSULE, EXTENDED RELEASE;ORAL - 325MG, CAPSULE, EXTENDED RELEASE;ORAL - 425MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 25 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 43 Direct Compression, 41 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 32 Granulation, 31 Thickeners and Stabilizers, 30 Solubilizers, 20 Lubricants & Glidants, 19 Co-Processed Excipients, 17 Film Formers & Plasticizers, 15 Topical, 14 Taste Masking, 12 Parenteral, 10 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 9 Empty Capsules, 6 API Stability Enhancers, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

13 NEWS #PharmaBuzz

13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 33 Finished Drug Prices

MARKET PLACE

7 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 19151 / DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPAFENONE HYDROCHLORIDE(UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U)	PROPAFENONE HYDROCHLORIDE	150mg \| 225mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline LLC
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Alpharma Brand of Propafenone Hydrochloride