Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sofosbuvir, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for sofosbuvir, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for sofosbuvir, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sofosbuvir, filing since 2017. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for sofosbuvir. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for sofosbuvir. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sofosbuvir, filing since 2019. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
08 United States
Makes the API
Registered with SFDA (Saudi Arabia) for sofosbuvir. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Holds one active US DMF for sofosbuvir, filing since 2014.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds one active US DMF for sofosbuvir, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
11 United States
Makes the API
Registered with SFDA (Saudi Arabia) for sofosbuvir. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 12 Saudi Arabia
Makes the API
Registered with SFDA (Saudi Arabia) for sofosbuvir.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for sofosbuvir.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 14 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for sofosbuvir. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 11 more manufacturers hold filings for sofosbuvir
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 Finished-dose makers (36)
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