Molecules / Dexmethylphenidate / United States

Dexmethylphenidate API manufacturers in United States

CAS 40431-64-9 ATC N06BA11 Updated 9 July 2026
11
United States-based manufacturers with an active filing of 8 worldwide
Showing 6 of 11 United States-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked United States-based API manufacturers

01

Ampac Fine Chemicals

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

Holds one active US DMF for dexmethylphenidate, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Curia

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

Holds one active US DMF for dexmethylphenidate, filing since 2007. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Siegfried

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

Holds one active US DMF for dexmethylphenidate, filing since 1998. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Specgx

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

Holds one active US DMF for dexmethylphenidate, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Purisys

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

Holds one active US DMF for dexmethylphenidate, filing since 2016. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Veranova Lp

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

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

5 more manufacturers in United States hold filings for dexmethylphenidate

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

CuriaSiegfriedSpecgxPurisysVeranova Lp
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How this list is built

This page filters the worldwide Dexmethylphenidate 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.

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All Dexmethylphenidate manufacturers

Worldwide 8