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Pipeline Prospector August 2025: Novo’s Wegovy approved for MASH, Tonix Pharma’s fibromyalgia drug okayed

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ACTIVE PHARMA INGREDIENTS

123 API Suppliers, 42 USDMF, 37 CEP/COS, 8 JDMF, 17 EU WC, 24 KDMF, 33 NDC API, 2 VMF, 58 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

176 Drugs in Development

176 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1036 FDF Dossiers, 96 FDA Orange Book, 571 Europe, 11 Canada, 123 Australia, 40 South Africa, 195 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 7 Evonik, 5 Rochem International Inc, 21 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 7 Kirsch Pharma, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 40 BASF, 1 Bioplus Life Sciences, 4 CD Formulation, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 2 Esteem Industries, 4 Finar, 13 Gangwal Chemicals, 13 Ideal Cures, 5 Ingredion Pharma Solutions, 25 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 74 Coating Systems & Additives, 50 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 45 Direct Compression, 44 Solubilizers, 44 Controlled & Modified Release, 41 Granulation, 32 Taste Masking, 30 Topical, 29 Lubricants & Glidants, 24 Chewable & Orodispersible Aids, 23 Parenteral, 22 Film Formers & Plasticizers, 16 Co-Processed Excipients, 13 Emulsifying Agents, 12 Rheology Modifiers, 9 Empty Capsules, 7 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

86 News #PharmaBuzz

86 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 523 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

65 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

15 US Patents, 15 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 61 Others

ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

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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
04/09/2025	Metrochem API Private Limited	India	M/s Metrochem API Private Limited	WC-0493	Omeprazole USP/Ph.Eur.	2024-04-03	2027-01-21	Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), Anakapalli District -531021, Andhra Pradesh, India
06/09/2025	Dr. Reddy's Laboratories	India	M/s Dr. Reddys Laboratories Limited	WC-0035	Omeprazole Ph. Eur	28-05-2025	25-06-2028	Chemical Technical Operations, Unit -Ill, Plot No. 116,Sri Venkateswara Co-operative Industrial Estate, IDA,Bollaram (Village), Jinnaram (Mandal), Sangareddy (Dist.),Telangana State, India

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

123 API Suppliers

42 USDMF

37 CEP/COS

8 JDMF

17 EU WC

24 KDMF

33 NDC API

2 VMF

58 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

176 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1036 FDF Dossiers

96 FDA Orange Book

571 Europe

11 Canada

123 Australia

40 South Africa

195 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 325MG;40MG

TABLET, DELAYED RELEASE;ORAL - 81MG;40MG

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

7 Evonik

5 Rochem International Inc

21 SPI Pharma

15 DKSH

2 Pharm-RX Chemical

10 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

7 Kirsch Pharma

4 ACG Worldwide

9 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

40 BASF

1 Bioplus Life Sciences

4 CD Formulation

15 Corel Pharma Chem

7 DFE Pharma

3 Doshion Polyscience

2 Esteem Industries

4 Finar

13 Gangwal Chemicals

13 Ideal Cures

5 Ingredion Pharma Solutions

25 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

2 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons