Initially, the products from the facility will cater to local markets but they would be taken gradually to global markets
Biotechnology major Biocon said its manufacturing facility in Malaysia will be commercialised in the second half of the current financial year.
“Our facility in Malaysia will be commercialised in the H2 of the current fiscal,” Biocon Chairperson and MD Kiran Mazumdar-Shaw told PTI during a conference call on the Q2 FY 17 results.
Initially, the products from the facility will cater to local markets but they would be taken gradually to global markets, she added.
The facility manufactures the drug substance for the company’s range of rh-insulin and insulin analogs as well as drug products in vials, cartridges and devices.
The rh-Insulin became the first product to be manufactured at this facility that has been approved for commercialisation by the Ministry of Health (MoH), Malaysia, as per the company’s website.
Regulatory filings for several other emerging markets are underway to enable commercial sales from the Malaysian facility, Biocon had said earlier.
The facility has received the cGMP certification from the National Pharmaceutical Control Bureau (NPCB), Malaysia.
Biocon’s Malaysia facility is located within BioXcell, a biotech park in Nusajaya, Johor, promoted by the Malaysian government.
According to the company’s website, this is Biocon’s first overseas biopharma manufacturing and research facility.