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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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Dolutegravir

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 25 USDMF, 10 EU WC, 2 KDMF, 13 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

42 Intermediate Suppliers

42 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 28 FDA Orange Book, 10 Europe, 5 Canada, 1 Australia, 59 South Africa, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 22 Kerry, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 24 Direct Compression, 22 Coating Systems & Additives, 21 Disintegrants & Superdisintegrants, 19 Granulation, 17 Thickeners and Stabilizers, 17 Lubricants & Glidants, 16 Solubilizers, 15 Controlled & Modified Release, 14 Co-Processed Excipients, 13 Chewable & Orodispersible Aids, 12 Taste Masking, 10 Topical, 10 Parenteral, 5 Film Formers & Plasticizers, 3 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 127 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 12 Regulatory FDF Prices, 32 Annual Reports

MARKET PLACE

9 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 5 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
29/03/2025	Arene Lifesciences	India	Arene Life Sciences Private Limited	WC-0487	Dolutegravir Sodium IHS	2023-12-26	2026-03-12	M/s Arene Life Sciences Private Limited 2 6 bol 08\r\nPlot No. 48-50, 209-211, IDA, Phase -ll, 4\r\nPashamylaram, Patancheru,\r\nSangareddy District -502307, Telangana State
22/11/2023	Aurore Life Sciences	India	M/s Aurore Pharmaceuticals Private Limited	WC-0119	Dolutegravir sodium IH	2022-09-19	2025-07-02	Plot No. 35, 36, 38, 39,40,49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal- Malkajgiri District, Telangana State, India

Dolutegravir

Dolutegravir

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers

25 USDMF

10 EU WC

2 KDMF

13 NDC API

34 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

INTERMEDIATES

42 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers

28 FDA Orange Book

10 Europe

5 Canada

1 Australia

59 South Africa

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

15 SPI Pharma

3 DKSH

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

20 BASF

5 Corel Pharma Chem

5 DFE Pharma

1 Finar

7 Gangwal Chemicals

3 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

22 Kerry

12 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

13 Roquette

2 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders

24 Direct Compression

22 Coating Systems & Additives

21 Disintegrants & Superdisintegrants

19 Granulation

17 Thickeners and Stabilizers

17 Lubricants & Glidants

16 Solubilizers

TABLET;ORAL - EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons