Suppliers / SM Biomed Sdn.Bhd

SM Biomed Sdn.Bhd

Malaysia 88 employees Updated 9 July 2026

SM Biomed Sdn.Bhd is an API and finished-dose 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.

8
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Molecule Regulators Docs
Erythromycin US FDA 8

Also appears on these molecule pages

Amoxicilin finished dose Cefoperazone finished dose Erythromycin API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 13 None
US FDA None 1

Questions about SM Biomed Sdn.Bhd

Does SM Biomed Sdn.Bhd hold a US DMF or a CEP?
SM Biomed Sdn.Bhd holds 8 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is SM Biomed Sdn.Bhd FDA-registered?
One site operated by SM Biomed Sdn.Bhd carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did SM Biomed Sdn.Bhd's last inspection go?
The most recent inspection on record closed on 28 July 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does SM Biomed Sdn.Bhd manufacture?
1 registered site is on record, in Malaysia (Malaysia). Every site is listed on this page with the register it came from.
What does SM Biomed Sdn.Bhd make?
1 molecule is on record against SM Biomed Sdn.Bhd, including Erythromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise SM Biomed Sdn.Bhd's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 28 July 2023.

Comparable suppliers

Apitoria Pharma shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Biophore India Pharmaceuticals shares 1 molecule Solara Active Pharma Sciences shares 1 molecule Gland Pharma shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates