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

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Trandolapril

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 6 CEP/COS, 3 JDMF, 2 EU WC, 3 NDC API, 6 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

136 FDF Dossiers, 33 FDA Orange Book, 38 Europe, 25 Canada, 28 Australia, 8 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Panvo Organics, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 27 Direct Compression, 25 Granulation, 23 Controlled & Modified Release, 19 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 12 Co-Processed Excipients, 12 Solubilizers, 9 Chewable & Orodispersible Aids, 9 Topical, 8 Film Formers & Plasticizers, 7 Taste Masking, 5 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Parenteral, 4 Vegetarian Capsules, 3 Emulsifying Agents, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 News #PharmaBuzz

3 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 15 Regulatory FDF Prices

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

22 Health Canada Patents

22 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 6 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Labeler	NDC Package Code	Non Proprietary Name	Start Marketing Date	End Marketing Date	Category Code	Dosage Form (Strength)
03/02/2026	Alivus Life Sciences	India	Alivus Life Sciences Limited	66039-811	Trandolapril	2005-03-14	2027-12-31	BULK INGREDIENT	POWDER (1kg/kg)
29/01/2026	Aurobindo Pharma Limited	India	Aurobindo Pharma Limited	65862-386	Trandolapril	2024-01-16	2026-12-31	BULK INGREDIENT	POWDER (50kg/50kg)

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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.

Trandolapril

Trandolapril

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers

7 USDMF

6 CEP/COS

3 JDMF

2 EU WC

3 NDC API

6 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

136 FDF Dossiers

33 FDA Orange Book

38 Europe

25 Canada

28 Australia

8 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

5 SPI Pharma

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Panvo Organics

1 ACG Worldwide

3 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

17 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

7 Gangwal Chemicals

5 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

16 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders

40 Coating Systems & Additives

27 Direct Compression

25 Granulation

23 Controlled & Modified Release

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons