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Malaysian Subsidiary of Major Biopharmaceutical Company Receives GMP Certification for Compliance

Insulin Glargine Manufacturing Facility for Biocon Sdn. Bhd. announced in August 2019 that it was awarded the EU Certification for GMP compliance.

The Malaysian subsidiary of one of Asia’s major bio-pharmaceutical companies, Biocon Ltd, has received the Certificate of GMP (Good Manufacturing Practice) compliance from the European Medicines Agency. It was presented to Biocon by the representative European inspection authority, Health Products Regulatory Authority (Ireland). This approval expands Biocon’s capacities to new large-scale device facilities to serve the growing needs of people with diabetes in the European Union (EU).

The manufacturing site in Malaysia was inspected in May 2019 and the certificate of GMP compliance received now reflects that the agency considers the manufacturing facilities for Drug Substances, Drug Products and Insulin Delivery Devices to be compliant with the guidelines of Good Manufacturing Practices.

Biocon’s recombinant human Insulin (rh-Insulin) is registered in over 40 countries worldwide and has been commercialized in many emerging markets. The Company’s biosimilar Insulin Glargine has been approved in over 60 countries and is commercialized in several key emerging markets.

Biocon through its biosimilars portfolio is committed to serve the needs of patients, people & partners by providing innovative affordable healthcare solutions going beyond the product. Biocon’s Biologics Business started FY20 on a very strong note with a robust revenue growth of 96% at Rs 490 Cr in Q1FY20. This Business aims to impact 2.6 million patient lives in FY20 and aspires to position the company as a global leader. [APBN]