Suppliers / Duopharma M Sdn Bhd

Duopharma M Sdn Bhd

Malaysia Updated 9 July 2026

Duopharma M Sdn Bhd is a finished-dose manufacturer based in Malaysia. It appears in 179 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), DAV (Vietnam) and FDA (GH). Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
1
registered plants
179
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Petaling, Malaysia Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 171 None
DAV (Vietnam) 6 None
FDA (GH) 2 None
EMA None 1

Questions about Duopharma M Sdn Bhd

Does Duopharma M Sdn Bhd hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Duopharma M Sdn Bhd. It does have 179 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Duopharma M Sdn Bhd manufacture?
1 registered site is on record, in Malaysia (Petaling). Every site is listed on this page with the register it came from.
Which regulators recognise Duopharma M Sdn Bhd's GMP?
Current GMP certificates are on record from EMA. 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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Sources on this page

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