Ranked API manufacturers
01 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and 2 valid CEPs for methylphenidate, filing since 1997. 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 valid CEPs for methylphenidate, filing since 2022. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methylphenidate, filing since 2016. Its GMP is recognised in 21 markets.
Last FDA inspection
Not established
GMP recognised in
21 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for methylphenidate, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
05 Brazil
Makes the APIFinished dose
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
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for methylphenidate, filing since 2024. 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
07 Spain
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for methylphenidate, filing since 2022. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
08 Belgium
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for methylphenidate, filing since 2024. Its GMP is recognised in 7 markets.
Last FDA inspection
Not established
GMP recognised in
7 markets
09 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methylphenidate, filing since 2016. 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
10 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methylphenidate, filing since 2005. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
11 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for methylphenidate, filing since 2019. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for methylphenidate, filing since 2024. 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
13 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for methylphenidate, filing since 2002. Its 2022 FDA inspection closed as NAI.
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
14 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for methylphenidate, filing since 2010. 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
15 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for methylphenidate, filing since 2015. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
16 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methylphenidate, filing since 2003. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
17 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for methylphenidate, filing since 2008. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
18 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for methylphenidate, filing since 1993.
Last FDA inspection
Not established
GMP recognised in
Not established
15 more manufacturers hold filings for methylphenidate
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 Contract manufacturers (4)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (48)
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.