Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Data Compilation
#PharmaFlow

Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking

Stock Recap
#PipelineProspector

Repaglinide

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 12 USDMF, 11 CEP/COS, 3 JDMF, 8 EU WC, 2 KDMF, 8 NDC API, 16 Listed Suppliers, $ API Reference Price

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers, 31 FDA Orange Book, 191 Europe, 18 Canada, 6 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Corel Pharma Chem, 3 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 5 Kerry, 8 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 25 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

50 Fillers, Diluents & Binders, 30 Direct Compression, 22 Disintegrants & Superdisintegrants, 21 Thickeners and Stabilizers, 20 Granulation, 19 Solubilizers, 17 Lubricants & Glidants, 16 Film Formers & Plasticizers, 15 Taste Masking, 15 Topical, 15 Controlled & Modified Release, 15 Coating Systems & Additives, 15 Co-Processed Excipients, 12 Parenteral, 8 Chewable & Orodispersible Aids, 5 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 155 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

7 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	USV Private Limited	India	USV PRIVATE LTD	18329	REPAGLINIDE USP	2005-05-09	Active	II	N/A
28/10/2024	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	23068	REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE)	2009-08-24	Active	II	N/A

Repaglinide

Repaglinide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers

12 USDMF

11 CEP/COS

3 JDMF

8 EU WC

2 KDMF

8 NDC API

16 Listed Suppliers

$ API Reference Price

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers

31 FDA Orange Book

191 Europe

18 Canada

6 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;1MG

TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

3 DKSH

1 Jai Radhe Sales

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

5 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

27 BASF

1 Corel Pharma Chem

3 DFE Pharma

1 Doshion Polyscience

2 Finar

9 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

5 Kerry

8 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

25 Roquette

1 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

1 Ulanqab Kema New Material

2 Valens Pharmachem

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

50 Fillers, Diluents & Binders

30 Direct Compression

22 Disintegrants & Superdisintegrants

21 Thickeners and Stabilizers

20 Granulation

19 Solubilizers

17 Lubricants & Glidants

16 Film Formers & Plasticizers

15 Taste Masking

TABLET;ORAL - 0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons