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

Beclomethasone Dipropionate Monohydrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 18 USDMF, 12 CEP/COS, 2 JDMF, 5 EU WC, 3 KDMF, 12 NDC API, 31 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

164 FDF Dossiers, 14 FDA Orange Book, 91 Europe, 7 Canada, 4 Australia, 14 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - EQ 0.042MG DIPROP/SPRAY, AEROSOL, METERED;NASAL - 0.04MG/ACTUATION, AEROSOL, METERED;NASAL - 0.08MG/ACTUATION, AEROSOL, METERED;INHALATION - 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 1 DKSH, 1 Jai Radhe Sales, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 6 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Kerry, 1 Kima Chemical, 6 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 1 Prachin Chemical, 8 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 1 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Fillers, Diluents & Binders, 16 Thickeners and Stabilizers, 15 Solubilizers, 14 Direct Compression, 10 Co-Processed Excipients, 7 Parenteral, 6 Controlled & Modified Release, 6 Disintegrants & Superdisintegrants, 5 Rheology Modifiers, 5 Granulation, 4 Coating Systems & Additives, 4 Film Formers & Plasticizers, 3 Emulsifying Agents, 3 Taste Masking, 3 Topical, 2 Chewable & Orodispersible Aids, 2 Lubricants & Glidants, 2 Surfactant & Foaming Agents, 1 API Stability Enhancers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 17 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 79 Finished Drug Prices, 4 Annual Reports

MARKET PLACE

13 APIs, 2 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

52 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 JP, 3 Others

$ 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	Axplora	Germany	FARMABIOS SPA	12813	BECLOMETHASONE DIPROPIONATE	1998-01-05	Active	II	Complete	2019-04-25	2019-04-22
28/10/2024	Symbiotec Pharmalab	India	SYMBIOTEC PHARMALAB PRIVATE LTD	28137	BECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED)	2014-03-20	Active	II	N/A

Beclomethasone Dipropionate Monohydrate

Beclomethasone Dipropionate Monohydrate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers

18 USDMF

12 CEP/COS

2 JDMF

5 EU WC

3 KDMF

12 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

164 FDF Dossiers

14 FDA Orange Book

91 Europe

7 Canada

4 Australia

14 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - EQ 0.042MG DIPROP/SPRAY

AEROSOL, METERED;NASAL - 0.04MG/ACTUATION

AEROSOL, METERED;NASAL - 0.08MG/ACTUATION

AEROSOL, METERED;INHALATION - 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

AEROSOL, METERED;INHALATION - 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

1 SPI Pharma

1 DKSH

1 Jai Radhe Sales

6 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

6 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 BASF

2 DFE Pharma

1 Finar

6 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

4 Kerry

1 Kima Chemical

6 Microlex e.U

1 Nanjing Bold Chemical

1 Pharmatrans-Sanaq

1 Pluviaendo

1 Prachin Chemical

8 Roquette

6 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

8 Sigachi Industries

1 The Dow Chemical Company

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Fillers, Diluents & Binders

16 Thickeners and Stabilizers

15 Solubilizers

14 Direct Compression

10 Co-Processed Excipients

7 Parenteral

6 Controlled & Modified Release

6 Disintegrants & Superdisintegrants

5 Rheology Modifiers

5 Granulation

4 Coating Systems & Additives

4 Film Formers & Plasticizers

3 Emulsifying Agents

3 Taste Masking

3 Topical

2 Chewable & Orodispersible Aids

2 Lubricants & Glidants

2 Surfactant & Foaming Agents

1 API Stability Enhancers

DIGITAL CONTENT

AEROSOL, METERED;INHALATION - 0.04MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

AEROSOL, METERED;INHALATION - 0.08MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons