Molecules / Benazepril

Benazepril API manufacturers

CAS 86541-75-5 ATC C09AA07 · ACE inhibitors Updated 9 July 2026
13
manufacturers with an active filing 12 of them hold a US DMF or a CEP
13
shortage records on file across 4 countries
85
finished-dose makers across 20 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lupin

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

W. R. Grace & Co.-Conn

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2000. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Zydus Lifesciences

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Nuray Chemicals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2022. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Farmhispania

Spain
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2001. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for benazepril, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Wisdom Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2019. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Aarti Pharmalabs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for benazepril, filing since 2006. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

ScinoPharm Taiwan

Taiwan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2002. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Unimark Remedies

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2006. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Amino Chemicals

Malta
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for benazepril, filing since 2006. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Registered with DAV (Vietnam) for benazepril. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

10 more manufacturers hold filings for benazepril

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Nuray ChemicalsFarmhispaniaApitoria PharmaWisdom PharmaceuticalAarti PharmalabsScinoPharm TaiwanUnimark RemediesAmino ChemicalsZhejiang Huahai PharmaceuticalCông ty cổ phần dược phẩm SaVi
Open the full list with a free account

Contract manufacturers (2)

Lgm Pharma United States Farmhispania Group Spain

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (25)

Amneal United States Dr. Reddy's Laboratories India Elanco US United States Novartis Switzerland Apotex Canada Teva Israel Viatris United States Amneal Pharmaceuticals NY United States Chartwell RX United States Ceva Santé Animale France Ems S/A Brazil Mylan Dublin Ireland Công ty cổ phần dược phẩm Đạt Vi Phú (Địa chỉ: Lô M7A, Đường D17, Khu Công nghiệp Mỹ Phước 1, Phường Thới Hòa, Thị xã Bến Cát, Tỉnh Bình Dương, Việt Nam) Vietnam Rising United States Dechra Eg S P A Italy Sandoz Switzerland 'Công ty cổ phần dược phẩm ME DI SUN Vietnam Công ty Cổ phần Dược phẩm OPV Vietnam Công ty cổ phần Dược phẩm An Thiên Vietnam

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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Also on this molecule

Shortages 13 Recalls 1 Finished dose 25 Contract mfrs 2

By country

India 10

Sold in these combinations

Benazepril + Amlodipine 2 APIs Benazepril + Hydrochlorothiazide 2 APIs

Fixed-dose combinations containing benazepril. Each page leads with the verified API makers of every component.