Ranked United States-based 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
02 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
03 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
04 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
05 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
06 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
07 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
08 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
09 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
8 more manufacturers in United States 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 How this list is built
This page filters the worldwide Methylphenidate manufacturer list to
companies based in United States. 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.
Read the full method.