Ranked API manufacturers
01 Sweden
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 6 active US DMFs and 4 valid CEPs for lactulose, filing since 2001. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for lactulose, filing since 2024. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for lactulose, filing since 1990. Its 2020 FDA inspection closed as VAI.
Last FDA inspection
2020 · VAI
GMP recognised in
Not established
04 Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for lactulose, filing since 2010. Its GMP is recognised in 4 markets.
Last FDA inspection
Not established
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for lactulose, filing since 2025.
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 lactulose, filing since 1984.
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 lactulose, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
08 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for lactulose. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 09 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for lactulose. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 6 more manufacturers hold filings for lactulose
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 Contract manufacturers (2)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (56)
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.