Molecules / Dextroamphetamine

Dextroamphetamine API manufacturers

CAS 51-64-9 ATC N06BA02 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
21
shortage records on file across 1 countries
66
finished-dose makers across 6 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Siegfried

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

Holds 3 active US DMFs for dextroamphetamine, filing since 2016. Its 2025 FDA inspection closed as NAI.

US DMF
3 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
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02

Specgx

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

Holds 5 active US DMFs for dextroamphetamine, filing since 2001. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
5 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
03

Chattem Chemicals

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

Holds 3 active US DMFs for dextroamphetamine, filing since 2017. Its 2022 FDA inspection closed as NAI.

US DMF
3 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Cambrex Charles City

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

Holds 2 active US DMFs for dextroamphetamine, filing since 2001. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Veranova Lp

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

Holds 4 active US DMFs for dextroamphetamine, filing since 2000.

US DMF
4 active
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
06

Curia

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

Holds 3 active US DMFs for dextroamphetamine, filing since 2002. Its 2026 FDA inspection closed as OAI.

US DMF
3 active
CEP
None on file
Last FDA inspection
2026 · OAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

3 more manufacturers hold filings for dextroamphetamine

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

Cambrex Charles CityVeranova LpCuria
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Finished-dose makers (18)

Amneal United States Glenmark Pharmaceuticals s.r.o Czech Republic Teva Israel Amneal Pharmaceuticals of New York United States Epic Pharma United States Granules India India Lupin India Gsk Vaccines United Kingdom ANI Pharmaceuticals United States Aurolife Pharma United States Lannett United States Oryza Pharmaceuticals United States Sandoz Switzerland Zydus Lifesciences India Alkem Laboratories India Ferndale Laboratories United States ACE Pharmaceuticals Netherlands KVK-Tech United States

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

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Also on this molecule

Shortages 21 Recalls 10 Finished dose 18 Contract mfrs 0

By country

United States 9

Sold in these combinations

Amphetamine + Dextroamphetamine 2 APIs

Fixed-dose combinations containing dextroamphetamine. Each page leads with the verified API makers of every component.