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Pipeline Prospector March 2025: Trump’s FDA overhaul spooks biotech stocks; Roche, AbbVie, Novo ink obesity drug deals

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Mioflex

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 27 USDMF, 2 JDMF, 4 EU WC, 13 KDMF, 17 NDC API, 22 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

151 FDF Dossiers, 94 FDA Orange Book, 28 Canada, 8 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 6 DKSH, 6 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 28 Disintegrants & Superdisintegrants, 27 Controlled & Modified Release, 26 Thickeners and Stabilizers, 24 Granulation, 22 Direct Compression, 17 Solubilizers, 16 Lubricants & Glidants, 15 Topical, 14 Film Formers & Plasticizers, 11 Taste Masking, 10 Co-Processed Excipients, 8 Parenteral, 6 Emulsifying Agents, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 API Stability Enhancers, 4 Coloring Agents

DIGITAL CONTENT

29 News #PharmaBuzz

29 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 Regulatory FDF Prices

4 Regulatory FDF Prices

MARKET PLACE

8 APIs, 2 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Synthokem Labs	India	SYNTHOKEM LABS PRIVATE LTD	10410	METHOCARBAMOL USP	1993-08-13	Active	II	Complete	2013-10-04	2013-09-30
28/03/2025	Granules India Limited	India	GRANULES INDIA LTD	17872	METHOCARBAMOL USP	2004-12-03	Active	II	Complete	2013-08-28	2013-08-12

Mioflex

Mioflex

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

64 API Suppliers

27 USDMF

2 JDMF

4 EU WC

13 KDMF

17 NDC API

22 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

151 FDF Dossiers

94 FDA Orange Book

28 Canada

8 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

4 SPI Pharma

6 DKSH

6 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

27 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

29 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

9 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders

49 Coating Systems & Additives

28 Disintegrants & Superdisintegrants

27 Controlled & Modified Release

26 Thickeners and Stabilizers

24 Granulation

22 Direct Compression

17 Solubilizers

16 Lubricants & Glidants

15 Topical

14 Film Formers & Plasticizers

11 Taste Masking

10 Co-Processed Excipients

8 Parenteral

6 Emulsifying Agents

6 Rheology Modifiers

6 Chewable & Orodispersible Aids

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons