Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for nicotine, filing since 2019. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
02 Switzerland
Makes the API
Holds 3 active US DMFs for nicotine, filing since 1988. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
4 markets
03 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and one valid CEP for nicotine, filing since 1989. Its 2021 FDA inspection closed as VAI.
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for nicotine, filing since 2024.
Last FDA inspection
Not established
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 nicotine, filing since 2015. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for nicotine, filing since 2023. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for nicotine, filing since 2010. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · 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 nicotine, filing since 2002. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for nicotine, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for nicotine, filing since 2021.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for nicotine, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
12 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for nicotine, filing since 2022.
Last FDA inspection
Not established
GMP recognised in
Not established
9 more manufacturers hold filings for nicotine
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (21)
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.