By: IPP Bureau
Last updated : October 26, 2022 9:52 am
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Biocon Biologics' integrated insulins manufacturing facility in Malaysia is approved by the European Medicines Agency following a site inspection in July 2022. The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
This approval reflects the agency's determination that the manufacturing facilities for Drug Substances, Drug Products, Insulin Delivery Device Assembly, as well as Secondary Packaging and Warehousing areas are in compliance with the guidelines of Good Manufacturing Practices.
This certificate enables the company to continue addressing the needs of people with diabetes in the EU who require Insulin Glargine and Insulin Aspart.
"Biocon Biologics remains committed to the global standards of Quality and Compliance," said a company spokesperson.