Molecules / Avanafil

Avanafil API manufacturers

CAS 330784-47-9 ATC G04BE10 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
10
shortage records on file across 2 countries
46
finished-dose makers across 28 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 APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for avanafil, filing since 2014. 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

Sanofi

France
Makes the API

Holds one active US DMF for avanafil, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 33 markets.

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

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for avanafil, filing since 2015. 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
04

Honour Lab

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

Holds one active US DMF for avanafil, filing since 2015. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Reyoung Pharmaceuticals

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

Holds one active US DMF for avanafil, filing since 2021. Its GMP is recognised in 4 markets.

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

Rakshit Pharmaceuticals

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

Holds one active US DMF for avanafil, filing since 2025. Its GMP is recognised in 1 market.

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

3 more manufacturers hold filings for avanafil

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

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Contract manufacturers (1)

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

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 avanafil?

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

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