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Pipeline Prospector Feb 2025: Bain buys Mitsubishi Tanabe for US$ 3.4 bn; Japan’s Ono gets FDA nod for rare joint tumor drug

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Sertraline

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ACTIVE PHARMA INGREDIENTS

83 API Suppliers, 25 USDMF, 25 CEP/COS, 7 JDMF, 23 EU WC, 15 KDMF, 15 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

17 Intermediate Suppliers

17 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers, 96 FDA Orange Book, 255 Europe, 54 Canada, 68 Australia, 25 South Africa, 62 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 SPI Pharma, 5 DKSH, 5 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 31 Controlled & Modified Release, 28 Disintegrants & Superdisintegrants, 26 Solubilizers, 26 Direct Compression, 24 Thickeners and Stabilizers, 22 Granulation, 20 Film Formers & Plasticizers, 19 Topical, 16 Parenteral, 16 Lubricants & Glidants, 12 Co-Processed Excipients, 8 Taste Masking, 8 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 28 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 217 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

17 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 15 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	16125	SERTRALINE HYDROCHLORIDE	2002-09-06	Inactive	II	N/A
28/03/2025	ALP Pharm	China	ALP PHARM BEIJING CO LTD	22145	SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)	2008-10-24	Inactive	II	N/A

Sertraline

Sertraline

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

83 API Suppliers

25 USDMF

25 CEP/COS

7 JDMF

23 EU WC

15 KDMF

15 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

17 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers

96 FDA Orange Book

255 Europe

54 Canada

68 Australia

25 South Africa

62 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 SPI Pharma

5 DKSH

5 Faran Shimi Pharmaceutical

6 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 ACG Worldwide

7 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

31 Kerry

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

12 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders

52 Coating Systems & Additives

TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons