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Propafenone HCl

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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TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 225MG, CAPSULE, EXTENDED RELEASE;ORAL - 325MG, CAPSULE, EXTENDED RELEASE;ORAL - 425MG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 Granulation, 32 Controlled & Modified Release, 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 Empty Capsules, 9 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers, 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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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Axplora	Germany	PHARMAZELL GMBH	10641	PROPAFENONE HYDROCHLORIDE	1993-12-16	Active	II	Complete	2013-03-07	2013-02-15
28/10/2024	Fermion Oy	Finland	FERMION OY	11568	PROPAFENONE HCL	1995-06-29	Active	II	Complete	2014-05-23	2014-05-14

Propafenone HCl

Propafenone HCl

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CHEMISTRY

Discover Molecule Insights

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

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 Granulation

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