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Fexofenadine

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ACTIVE PHARMA INGREDIENTS

78 API Suppliers, 24 USDMF, 12 CEP/COS, 15 JDMF, 14 EU WC, 10 KDMF, 25 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

26 Intermediates Suppliers

26 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers, 96 FDA Orange Book, 76 Europe, 4 Canada, 5 Australia, 30 South Africa, 77 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 30MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG, SUSPENSION;ORAL - 30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 11 DKSH, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 1 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 54 Direct Compression, 44 Thickeners and Stabilizers, 43 Disintegrants & Superdisintegrants, 36 Controlled & Modified Release, 36 Granulation, 31 Solubilizers, 31 Taste Masking, 29 Lubricants & Glidants, 28 Film Formers & Plasticizers, 23 Chewable & Orodispersible Aids, 22 Topical, 22 Co-Processed Excipients, 20 Parenteral, 9 Empty Capsules, 9 API Stability Enhancers, 8 Emulsifying Agents, 7 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

74 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

32 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 13 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 JP, 6 Others

ANALYTICAL

1 BioAnalytical Methods, 5 Analytical 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	Virupaksha Organics	India	VIRUPAKSHA ORGANICS LTD	23070	FEXOFENADINE HCL (FORM-1) USP	2009-08-10	Active	II	Complete	2014-07-15	2014-06-27
28/10/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	15757	FEXOFENADINE HYDROCHLORIDE	2001-12-05	Active	II	Complete	2020-12-12	2020-12-04

Fexofenadine

Fexofenadine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

78 API Suppliers

24 USDMF

12 CEP/COS

15 JDMF

14 EU WC

10 KDMF

25 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

26 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers

96 FDA Orange Book

76 Europe

4 Canada

5 Australia

30 South Africa

77 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 30MG/5ML

TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

TABLET;ORAL - 180MG

TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

TABLET, ORALLY DISINTEGRATING;ORAL - 30MG

SUSPENSION;ORAL - 30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem

6 Rochem International Inc

18 SPI Pharma

2 Seqens

11 DKSH

2 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

12 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

36 BASF

1 Bioplus Life Sciences

1 Clariant

11 Corel Pharma Chem

7 DFE Pharma

2 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

37 Kerry

4 Kima Chemical

6 Lonza Capsugel

18 Microlex e.U

2 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

29 Roquette

13 Seppic

TABLET;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons