FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Biocon Gets EMA Signoff on Malaysian Insulin Plant

Sept. 14, 2017
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Biocon has secured the EU’s approval to build an insulin plant in Malaysia, according to the drugmaker.

The $275 million facility in Johor earned an EMA manufacturing certificate to manufacture sterile drug products and active substances following an April inspection. The facility already had 600 employees to manufacture insulin analogs and recombinant human insulin.

The approval makes the plant Biocon’s first biopharma processing location outside of India. The company began the project in 2010 when uncertainty in the Indian economy spurred it to seek manufacturing infrastructure elsewhere.

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