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Butalbital

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 8 USDMF, 9 NDC API, 2 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

129 FDF Dossiers, 113 FDA Orange Book, 8 Canada, 8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 2 Rochem International Inc, 7 SPI Pharma, 12 DKSH, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 7 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 30 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 8 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 31 Thickeners and Stabilizers, 29 Direct Compression, 28 Controlled & Modified Release, 28 Granulation, 24 Lubricants & Glidants, 18 Taste Masking, 18 Film Formers & Plasticizers, 15 Solubilizers, 14 Topical, 12 Chewable & Orodispersible Aids, 12 Parenteral, 11 Co-Processed Excipients, 9 Empty Capsules, 5 Coloring Agents, 5 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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27 News #PharmaBuzz

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1 APIs

REF. STANDARDS & IMPURITIES

1 USP, 4 Others

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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
28/03/2025	Chemische Fabrik Berg	Germany	CHEMISCHE FABRIK BERG GMBH	4395	BUTALBITAL	1981-11-25	Active	II	Complete	2013-03-06	2013-02-20
28/03/2025	Cambrex Corporation	U.S.A	CAMBREX CHARLES CITY INC	17054	BUTALBITAL	2003-12-12	Inactive	II	N/A

Butalbital

Butalbital

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

9 API Suppliers

8 USDMF

9 NDC API

2 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

129 FDF Dossiers

113 FDA Orange Book

8 Canada

8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

2 Rochem International Inc

7 SPI Pharma

12 DKSH

6 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

7 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

4 ACG Worldwide

7 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

30 BASF

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

30 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

30 Roquette

8 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders

51 Coating Systems & Additives

40 Disintegrants & Superdisintegrants

31 Thickeners and Stabilizers

29 Direct Compression

28 Controlled & Modified Release

TABLET;ORAL - 325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons