FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

Data Compilation
#PharmaFlow

Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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Tradjenta (TN)

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ACTIVE PHARMA INGREDIENTS

130 API Suppliers, 31 USDMF, 8 JDMF, 19 EU WC, 48 KDMF, 18 NDC API, 77 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

66 Drugs in Development

66 Drugs in Development

INTERMEDIATES

92 Intermediate Suppliers

92 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers, 48 FDA Orange Book, 106 Europe, 4 Canada, 12 Australia, 42 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - 10MG;5MG, TABLET;ORAL - 25MG;5MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 5 DKSH, 2 Boai NKY Pharmaceuticals Ltd, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 BASF, 10 Corel Pharma Chem, 1 Finar, 4 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 3 Ideal Cures, 2 Ingredion Pharma Solutions, 9 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 3 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 8 Roquette, 7 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 1 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 26 Fillers, Diluents & Binders, 13 Controlled & Modified Release, 12 Lubricants & Glidants, 11 Film Formers & Plasticizers, 10 Direct Compression, 8 Thickeners and Stabilizers, 6 Taste Masking, 5 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 5 Granulation, 5 Solubilizers, 4 Chewable & Orodispersible Aids, 4 Co-Processed Excipients, 4 Disintegrants & Superdisintegrants, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Topical, 3 Rheology Modifiers, 2 Parenteral

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 75 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

31 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

304 US Patents, 12 US Exclusivities, 59 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 12 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
30/12/2025	Honour Lab Limited	India	Pharmapia Co., Ltd.	Su4579-15-ND(4)	Linagliptin	2024-09-05	Honour Lab Limited Unit III	India	Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, Anakapalli District - 531 081, Andhra Pradesh, India
30/12/2025	Dr. Reddy\'s Laboratories	India	Pamirae Co., Ltd.	Su574-8-ND	Linagliptin	2017-12-15	Dr. Reddy's Laboratories Limited	India	Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Tradjenta (TN)

Tradjenta (TN)

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

130 API Suppliers

31 USDMF

8 JDMF

19 EU WC

48 KDMF

18 NDC API

77 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

66 Drugs in Development

INTERMEDIATES

92 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers

48 FDA Orange Book

106 Europe

4 Canada

12 Australia

42 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG

TABLET;ORAL - 2.5MG;1GM

TABLET;ORAL - 2.5MG;500MG

TABLET;ORAL - 2.5MG;850MG

TABLET;ORAL - 10MG;5MG

TABLET;ORAL - 25MG;5MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma

5 DKSH

2 Boai NKY Pharmaceuticals Ltd

1 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Kirsch Pharma

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 BASF

10 Corel Pharma Chem

1 Finar

4 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

3 Ideal Cures

2 Ingredion Pharma Solutions

9 Kerry

3 Kima Chemical

6 Lonza Capsugel

7 Microlex e.U

1 Nitika Pharmaceutical Specialities

2 Novo Excipients

3 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

8 Roquette

7 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Sigachi Industries

1 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives

26 Fillers, Diluents & Binders

13 Controlled & Modified Release

12 Lubricants & Glidants

11 Film Formers & Plasticizers

10 Direct Compression

8 Thickeners and Stabilizers

6 Taste Masking

5 Emulsifying Agents

5 Empty Capsules