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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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Sildenafil Citrate

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 20 USDMF, 21 CEP/COS, 5 JDMF, 18 EU WC, 14 KDMF, 28 NDC API, 48 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

36 Drugs in Development

36 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

575 FDF Dossiers, 102 FDA Orange Book, 181 Europe, 52 Canada, 35 Australia, 54 South Africa, 151 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 10MG BASE/ML, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 20MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 4 SPI Pharma, 7 DKSH, 2 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 7 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 12 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 32 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 29 Controlled & Modified Release, 22 Thickeners and Stabilizers, 19 Lubricants & Glidants, 17 Film Formers & Plasticizers, 17 Disintegrants & Superdisintegrants, 17 Direct Compression, 15 Granulation, 13 Topical, 11 Taste Masking, 10 Parenteral, 10 Co-Processed Excipients, 7 Solubilizers, 7 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

225 News #PharmaBuzz

225 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 84 Regulatory FDF Prices, 25 Annual Reports

MARKET PLACE

59 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 4 US Exclusivities, 30 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical 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	Polpharma	Poland	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	23930	SILDENAFIL CITRATE	2010-06-29	Active	II	Complete	2016-08-11	2016-06-13
28/03/2025	TAPI Technology & API Services	Israel	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	17778	SILDENAFIL CITRATE	2004-10-25	Active	II	Complete	2017-12-29	2017-12-11

Sildenafil Citrate

Sildenafil Citrate

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

20 USDMF

21 CEP/COS

5 JDMF

18 EU WC

14 KDMF

28 NDC API

48 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

36 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

575 FDF Dossiers

102 FDA Orange Book

181 Europe

52 Canada

35 Australia

54 South Africa

151 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 10MG BASE/ML

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 20MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem

3 Rochem International Inc

4 SPI Pharma

7 DKSH

2 Pharm-RX Chemical

4 Faran Shimi Pharmaceutical

1 Chynops Pharma

7 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Pramukh Pharmachem

1 Zeal MediPharma

1 ACG Worldwide

5 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

12 BASF

1 Bioplus Life Sciences

1 Clariant

10 Corel Pharma Chem

5 DFE Pharma

1 Finar

8 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

32 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

25 Roquette

6 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem