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Nisoldipine

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 8 USDMF, 2 JDMF, 1 EU WC, 2 NDC API, 4 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 16 FDA Orange Book, 1 Europe, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 17MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 34MG, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8.5MG

RELATED EXCIPIENT COMPANIES

4 Evonik, 5 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 11 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 8 Ideal Cures Pvt Ltd, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives, 35 Fillers, Diluents & Binders, 28 Controlled & Modified Release, 15 Granulation, 14 Solubilizers, 12 Lubricants & Glidants, 10 Direct Compression, 10 Thickeners and Stabilizers, 9 Film Formers & Plasticizers, 8 Topical, 6 Co-Processed Excipients, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 3 Rheology Modifiers, 3 Parenteral, 2 Disintegrants & Superdisintegrants, 1 Chewable & Orodispersible Aids, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 News #PharmaBuzz

1 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Regulatory FDF Prices

REF. STANDARDS & IMPURITIES

5 Others

5 Others

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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	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	25365	NISOLDIPINE	2011-10-07	Active	II	Complete	2014-09-23	2013-09-26
28/03/2025	Bayer AG	Germany	BAYER AG	10167	NISOLDIPINE	1993-03-31	Active	II	N/A

Nisoldipine

Nisoldipine

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

11 API Suppliers

8 USDMF

2 JDMF

1 EU WC

2 NDC API

4 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers

16 FDA Orange Book

1 Europe

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 17MG

TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET, EXTENDED RELEASE;ORAL - 34MG

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

TABLET, EXTENDED RELEASE;ORAL - 8.5MG

RELATED EXCIPIENT COMPANIES

4 Evonik

5 DKSH

4 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

2 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

11 Corel Pharma Chem

2 DFE Pharma

1 Finar

5 Gangwal Chemicals

8 Ideal Cures Pvt Ltd

28 Kerry

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

3 Roquette

6 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Sigachi Industries

2 The Dow Chemical Company

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives

35 Fillers, Diluents & Binders

28 Controlled & Modified Release

15 Granulation

14 Solubilizers

12 Lubricants & Glidants

10 Direct Compression

10 Thickeners and Stabilizers

9 Film Formers & Plasticizers

8 Topical

6 Co-Processed Excipients

5 Empty Capsules

4 Emulsifying Agents

4 Vegetarian Capsules

4 API Stability Enhancers

4 Taste Masking

4 Coloring Agents

3 Rheology Modifiers

TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

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