The drug maker announced its receipt of the certificate in a Bombay Stock Exchange (BSE) filing last week, explaining the site in Johor successfully passed an HPRA audit in April.
The facility – which makes insulin active pharmaceutical ingredient (API), insulin analogues and finished products - is located at the Bio-XCell biotechnology park.
Construction plans were first announced in 2011 when Biocon said the plant would produce insulin for Pfizer under a 2010 contract.
The plant became operational after it was commissioned in 2015.
In May, Malaysia’s Ministry of Health contracted awarded Biocon a three-year contract to supply recombinant insulin made at the facility to healthcare clinics and hospitals across the country.
The HPRA's public relations agency did not respond to a request for confirmation.
Regulatory issue
Approval for the Malaysia site comes months after Biocon’s plant in Bangalore, India – which also makes biosimilars – was criticised by European and US regulators.
An inspection in March by France’s regulatory body ANSM (Agence Nationale de Sécurité du Médicament) resulted in a statement of non-compliance with GMP being issued to the Biocon in July, citing 35 issues at the facility.
A month later withdraw dossiers for trastuzumab and pegfilgrastim biosimilars it had previously filed with the European Medicines Agency (EMA).
And last month the FDA issued Biocon with a Form 483 with ten deviations observed during an inspection of the Bangalore facility in May and June.
UPDATE
HPRA told us "Following an inspection carried out at the request of the European Medicines Agency, a GMP certificate has been issued to the Biocon plant in Malaysia. The certificate is dated 6th September 2017 and has been uploaded to the EUdraGMDP database."