Molecules / Sacubitril/Valsartan

Sacubitril/Valsartan API manufacturers

CAS 936623-90-4 ATC C09DX04 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
22
finished-dose makers across 9 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for sacubitril/valsartan, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

Macleods Pharmaceuticals

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

Holds one active US DMF for sacubitril/valsartan, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Harman Finochem

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

Holds one active US DMF for sacubitril/valsartan, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

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

Amoli Organics

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

Holds 2 active US DMFs for sacubitril/valsartan, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for sacubitril/valsartan, filing since 2017. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Matrix Pharmacorp

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

Holds one active US DMF for sacubitril/valsartan, filing since 2017. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Zhuhai Rundu Pharmaceutical

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

Holds one active US DMF for sacubitril/valsartan, filing since 2021. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

4 more manufacturers hold filings for sacubitril/valsartan

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

Open the full list with a free account

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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