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

Etilevodopa

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 20 USDMF, 13 CEP/COS, 4 JDMF, 2 EU WC, 9 KDMF, 12 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

38 Drugs in Development

38 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

396 FDF Dossiers, 125 FDA Orange Book, 189 Europe, 25 Canada, 14 South Africa, 43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG, CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG, CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG, CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 3 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 47 Direct Compression, 46 Disintegrants & Superdisintegrants, 39 Controlled & Modified Release, 32 Thickeners and Stabilizers, 31 Solubilizers, 31 Granulation, 25 Taste Masking, 23 Lubricants & Glidants, 23 Film Formers & Plasticizers, 22 Parenteral, 21 Chewable & Orodispersible Aids, 20 Co-Processed Excipients, 13 Topical, 9 API Stability Enhancers, 8 Emulsifying Agents, 7 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 94 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

176 Finished Drug Prices, 16 Annual Reports

MARKET PLACE

23 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

111 US Patents, 4 US Exclusivities

REF. STANDARDS & IMPURITIES

1 EDQM, 3 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	Ajinomoto Company	Japan	AJINOMOTO CO INC	31654	LEVODOPA	2017-04-20	Active	II	N/A
28/10/2024	Ajinomoto Company	Japan	AJINOMOTO CO INC	12379	LEVODOPA	1997-02-19	Active	II	Complete	2017-08-17	2017-07-18

Etilevodopa

Etilevodopa

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers

20 USDMF

13 CEP/COS

4 JDMF

2 EU WC

9 KDMF

12 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

38 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

396 FDF Dossiers

125 FDA Orange Book

189 Europe

25 Canada

14 South Africa

43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

TABLET;ORAL - 12.5MG;200MG;50MG

TABLET;ORAL - 18.75MG;200MG;75MG

TABLET;ORAL - 25MG;200MG;100MG

TABLET;ORAL - 31.25MG;200MG;125MG

TABLET;ORAL - 37.5MG;200MG;150MG

TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

4 Rochem International Inc

20 SPI Pharma

2 Seqens

5 DKSH

3 Jai Radhe Sales

8 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

8 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

29 BASF

12 Corel Pharma Chem

6 DFE Pharma

1 Finar

12 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

5 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons