Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for alprazolam, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
02 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
03 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for alprazolam, filing since 1987. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for alprazolam, filing since 1991. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for alprazolam, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for alprazolam, filing since 2005. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
07 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for alprazolam, filing since 2023. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for alprazolam, filing since 2019. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
5 more manufacturers hold filings for alprazolam
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (5)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (88)
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
- Price band
-
Customs export unit values for 2025. These are export values rather than
contract prices for regulated-market grade material, which are higher.