Molecules / Revefenacin

Revefenacin API manufacturers

CAS 864750-70-9 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
10
finished-dose makers across 8 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for revefenacin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

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

Mankind Pharma

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

Holds 2 active US DMFs for revefenacin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Cipla

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

Holds one active US DMF for revefenacin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

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

Apitoria Pharma

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

Holds one active US DMF for revefenacin, filing since 2022. 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
05

Inke

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

Holds 2 active US DMFs for revefenacin, filing since 2022. Its 2023 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Medichem Manufacturing (Malta)

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

Holds one active US DMF for revefenacin, filing since 2022. Its 2018 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

3 more manufacturers hold filings for revefenacin

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Apitoria PharmaInkeMedichem Manufacturing (Malta)
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Contract manufacturers (1)

Inke Spain

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

Finished-dose makers (3)

Viatris United States Zydus Lifesciences India BDR Lifesciences India

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

Who makes revefenacin?

Ask Fred which manufacturers are on record for revefenacin and what filings they hold.

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Also on this molecule

Finished dose 3 Contract mfrs 1