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

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

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ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 26 USDMF, 10 CEP/COS, 10 JDMF, 17 EU WC, 26 KDMF, 16 NDC API, 14 Listed Suppliers, $ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

160 FDF Dossiers, 77 FDA Orange Book, 36 Europe, 15 Canada, 2 South Africa, 30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 15MG BASE, TABLET;ORAL - EQ 30MG BASE, TABLET;ORAL - EQ 45MG BASE, TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 16 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 27 BASF, 2 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 41 Direct Compression, 32 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 27 Solubilizers, 27 Thickeners and Stabilizers, 26 Granulation, 21 Co-Processed Excipients, 20 Topical, 20 Parenteral, 20 Lubricants & Glidants, 18 Film Formers & Plasticizers, 17 Taste Masking, 15 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 8 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 17 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 18 Finished Drug Prices

MARKET PLACE

11 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 6 JP, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
13/09/2024	Dr. Reddy\'s Laboratories	India	M/s Dr. Reddy's Laboratories	WC-0067	Pioglitazone Hydrochloride USP/EP/IH	2022-06-17	2025-07-07	Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District,, Andhra Pradesh 532409
16/01/2024	USV Private Limited	India	USV Private Limited	WC-0012	Pioglitazone Hydrochloride BPI Ph.Eur.lUSPI IH	2022-06-27	2025-06-02	MIs USV Private Limited ,B-1/8,MIDC, Lote Parshuram, Tal., Dist. Ratnagiri, Khed - 415722, Taluka: Khed, District: Ratnagiri

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers

26 USDMF

10 CEP/COS

10 JDMF

17 EU WC

26 KDMF

16 NDC API

14 Listed Suppliers

$ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

160 FDF Dossiers

77 FDA Orange Book

36 Europe

15 Canada

2 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 15MG BASE

TABLET;ORAL - EQ 30MG BASE

TABLET;ORAL - EQ 45MG BASE

TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 850MG;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

16 SPI Pharma

2 Seqens

4 DKSH

2 Jai Radhe Sales

6 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

5 Actylis

1 Aeon Procare

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

27 BASF

2 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

11 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

14 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

2 The Dow Chemical Company

3 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders

TABLET;ORAL - 500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons