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Prandase, Precose, Glucobay, Bay-g 5421, Acarbose
USDMF
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Prandase, Precose, Glucobay, Bay-g 5421, Acarbose

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 9 USDMF, 6 CEP/COS, 3 JDMF, 4 KDMF, 5 NDC API, 7 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers, 27 FDA Orange Book, 43 Europe, 2 Canada, 10 Australia, 2 South Africa, 31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 4 Gangwal Healthcare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures, 3 Ingredion Pharma Solutions, 1 Kerry, 2 Keval Exports, 7 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 14 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders, 16 Disintegrants & Superdisintegrants, 13 Direct Compression, 10 Lubricants & Glidants, 10 Co-Processed Excipients, 10 Thickeners and Stabilizers, 8 Granulation, 6 Chewable & Orodispersible Aids, 5 Taste Masking, 3 Controlled & Modified Release, 3 Emulsifying Agents, 2 Rheology Modifiers, 2 Coating Systems & Additives, 1 Film Formers & Plasticizers, 1 API Stability Enhancers

DIGITAL CONTENT

4 News #PharmaBuzz

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 33 Regulatory FDF Prices, 6 Annual Reports

MARKET PLACE

13 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 3 Others

$ Xls download

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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
31/10/2025	Bayer AG	Germany	BAYER AG	8539	ACARBOSE	1990-04-23	Active	II	N/A
31/10/2025	CKD Bio Corporation	South Korea	CKD BIO CORP	20759	ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE	2007-07-31	Active	II	Complete	2013-03-15	2013-02-26

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Prandase, Precose, Glucobay, Bay-g 5421, Acarbose

Prandase, Precose, Glucobay, Bay-g 5421, Acarbose

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers

9 USDMF

6 CEP/COS

3 JDMF

4 KDMF

5 NDC API

7 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers

27 FDA Orange Book

43 Europe

2 Canada

10 Australia

2 South Africa

31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

1 DKSH

4 Gangwal Healthcare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 DFE Pharma

4 Gangwal Chemicals

1 Ideal Cures

3 Ingredion Pharma Solutions

1 Kerry

2 Keval Exports

7 Microlex e.U

2 Nitika Pharmaceutical Specialities

1 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

14 Roquette

1 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

3 Silverline Chemicals

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders

16 Disintegrants & Superdisintegrants

13 Direct Compression

10 Lubricants & Glidants

10 Co-Processed Excipients

10 Thickeners and Stabilizers

8 Granulation

6 Chewable & Orodispersible Aids

5 Taste Masking

3 Controlled & Modified Release

3 Emulsifying Agents

2 Rheology Modifiers

2 Coating Systems & Additives

1 Film Formers & Plasticizers

1 API Stability Enhancers

DIGITAL CONTENT

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions

33 Regulatory FDF Prices

6 Annual Reports

MARKET PLACE

13 APIs

1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM

3 Others

Filters

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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