DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Data Compilation
#PharmaFlow

Pipeline Prospector Sept 2024: BMS wins landmark FDA approval for schizophrenia med; Sanofi’s Dupixent okayed for COPD

Stock Recap
#PipelineProspector

Nifedipine

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 9 CEP/COS, 7 JDMF, 4 EU WC, 7 KDMF, 19 NDC API, 17 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

273 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 8 Australia, 32 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 8 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 40 Controlled & Modified Release, 33 Direct Compression, 28 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 23 Granulation, 21 Solubilizers, 21 Parenteral, 20 Taste Masking, 20 Topical, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 106 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

20 APIs, 16 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 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	Moehs Iberica	Spain	MOEHS IBERICA SL	7504	NIFEDIPINE	1988-06-03	Active	II	Complete	2013-04-02	2013-03-25
28/10/2024	Bayer AG	Germany	BAYER HEALTHCARE AG	3672	NIFEDIPINE	1979-12-26	Inactive	II	N/A

Nifedipine

Nifedipine

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers

38 USDMF

9 CEP/COS

7 JDMF

4 EU WC

7 KDMF

19 NDC API

17 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

273 FDF Dossiers

75 FDA Orange Book

100 Europe

18 Canada

8 Australia

32 South Africa

40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG

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

TABLET, EXTENDED RELEASE;ORAL - 30MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 90MG

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

TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

2 Rochem International Inc

6 SPI Pharma

2 Seqens

12 DKSH

4 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

4 ACG Worldwide

8 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

26 BASF

1 Clariant

12 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

3 Finar

8 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

24 Roquette

10 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

CAPSULE;ORAL - 20MG 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 - 60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons