Molecules / United States

API manufacturers in United States

11 molecules 24 manufacturers Updated 9 July 2026

24 manufacturers based in United States hold an active filing across 11 molecules in this directory, and 22 of them hold a US DMF or a valid CEP.

24
manufacturers with an active filing22 hold a US DMF or a CEP
11
molecules made here7 where United States holds over half the makers we list
67%
have a published FDA inspection 2 carry an OAI

Molecules made in United States

Molecule In United States Worldwide Holding a DMF or CEP
Methylphenidate 11 18 9
Cannabidiol 9 20 7
Dexmethylphenidate 8 8 5
Fentanyl 8 13 6
Amphetamine 7 6 6
Dextroamphetamine 7 6 6
Hydrocodone 6 6 6
Codeine 5 26 5
Heparin 5 24 5
Hydromorphone 5 10 5
Oxycodone 5 7 5

How these figures are counted

Counts are of distinct companies, not filings, and cover the manufacturers in this directory rather than all production in United States. Shares are stated on that basis. How we count our figures.

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
GMP certificates
US FDA, ANVISA (Brazil), HSA (SG)

Questions

How many API manufacturers are based in United States?
24 distinct manufacturers based in United States hold an active regulatory filing for at least one of the 11 molecules covered here, and 22 hold a US drug master file or a valid CEP. Counts come from the FDA drug master file list, the EDQM certificate database and national registers, as at 9 July 2026.
Which regulators recognise United States sites?
GMP certificates held by these suppliers come from US FDA, ANVISA (Brazil), HSA (SG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.
How do United States suppliers perform on FDA inspections?
16 of the 24 suppliers here (67%) have a published FDA inspection classification, and 2 carry an OAI, the worst outcome. Suppliers never inspected do not appear in that count, so this describes the inspected population rather than all of United States.
Which molecules is United States strongest on?
United States holds more than half the manufacturers we list for 7 of 11 molecules. The table is ordered by how many United States-based makers each molecule has. Shares are of the manufacturers in this directory, not of world production.

Source from United States?

Tell us the molecules and the markets you file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

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Other countries

India 406 China 123 Italy 2

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