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Tolbutamide
USDMF
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Tolbutamide

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 10 USDMF, 3 CEP/COS, 4 NDC API, 2 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 18 FDA Orange Book, 1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 DKSH, 3 Gangwal Healthcare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures, 1 Ingredion Pharma Solutions, 1 Kerry, 2 Keval Exports, 7 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 9 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

19 Fillers, Diluents & Binders, 13 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 10 Thickeners and Stabilizers, 9 Granulation, 9 Direct Compression, 7 Co-Processed Excipients, 4 Controlled & Modified Release, 4 Coating Systems & Additives, 4 Taste Masking, 3 Chewable & Orodispersible Aids, 3 Emulsifying Agents, 1 API Stability Enhancers, 1 Topical, 1 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Film Formers & Plasticizers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 2 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
31/10/2025	Albert David	India	ALBERT DAVID LTD	5982	TOLBUTAMIDE USP	1985-09-04	Inactive	II	N/A
31/10/2025	Alfasigma	Italy	ALFA WASSERMANN SPA	466	TOLBUTAMIDE BULK	1962-02-15	Inactive	II	N/A

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Tolbutamide

Tolbutamide

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers

10 USDMF

3 CEP/COS

4 NDC API

2 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers

18 FDA Orange Book

1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

1 DKSH

3 Gangwal Healthcare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

5 BASF

3 DFE Pharma

4 Gangwal Chemicals

1 Ideal Cures

1 Ingredion Pharma Solutions

1 Kerry

2 Keval Exports

7 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Pharmatrans-Sanaq

2 Pluviaendo

3 Prachin Chemical

9 Roquette

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

3 Silverline Chemicals

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

19 Fillers, Diluents & Binders

13 Lubricants & Glidants

13 Disintegrants & Superdisintegrants

10 Thickeners and Stabilizers

9 Granulation

9 Direct Compression

7 Co-Processed Excipients

4 Controlled & Modified Release

4 Coating Systems & Additives

4 Taste Masking

3 Chewable & Orodispersible Aids

3 Emulsifying Agents

1 API Stability Enhancers

1 Topical

1 Rheology Modifiers

1 Surfactant & Foaming Agents

1 Film Formers & Plasticizers

REF. STANDARDS & IMPURITIES

1 EDQM

1 JP

2 Others

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