SM Biomed Sdn.Bhd
Malaysia 88 employees Updated 9 July 2026
SM Biomed Sdn.Bhd is an API manufacturer based in Malaysia. It holds 8 active US drug master files. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 July 2023 as VAI.
1
registered plants
1 with an FDA FEI number
13
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 28 July 2023 VAI US FDA
- 23 March 2018 VAI US FDA
- 11 March 2016 VAI US FDA
- 7 March 2013 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Malaysia, Malaysia | 3005983287 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| DAV (Vietnam) | 13 | None |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 28 July 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates