New Delhi, Biocon on Monday said its unit Biocon Biologics has received approval from the European Medicines Agency (EMA) to manufacture biosimilar bevacizumab at its new facility in Bengaluru.
This approval will provide significant additional capacity to meet the needs of patients across all markets in Europe, the company said in a statement.
Bevacizumab is used to treat health conditions such as colorectal cancer, lung cancer, and ovarian cancer.
The Bengaluru facility was earlier approved to manufacture biosimilar trastuzumab in September 2022.
Biocon said the EMA has also renewed its Good Manufacturing Practice (GMP) certificate of compliance for its biosimilar manufacturing facility in Bengaluru and insulin facility in Malaysia following regular GMP inspections. It said these certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of the EMA.
"These GMP certifications at our manufacturing sites in India and Malaysia reflect Biocon Biologics' continued adherence to the highest standards of quality and our unwavering commitment to meeting the needs of patients globally," a company spokesperson said.
Last week, Biocon had informed the stock markets that the US health regulator had issued four observations after inspecting its Andhra Pradesh-based manufacturing plant.
The US Food and Drug Administration (USFDA) completed the GMP inspection of the Company's API facility (Site 5) located in Visakhapatnam, Andhra Pradesh on June 21, 2024.
Biocon shares were trading 0.54 per cent lower at Rs 343.75 on BSE.
This approval will provide significant additional capacity to meet the needs of patients across all markets in Europe, the company said in a statement.
Bevacizumab is used to treat health conditions such as colorectal cancer, lung cancer, and ovarian cancer.
The Bengaluru facility was earlier approved to manufacture biosimilar trastuzumab in September 2022.
Biocon said the EMA has also renewed its Good Manufacturing Practice (GMP) certificate of compliance for its biosimilar manufacturing facility in Bengaluru and insulin facility in Malaysia following regular GMP inspections. It said these certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of the EMA.
"These GMP certifications at our manufacturing sites in India and Malaysia reflect Biocon Biologics' continued adherence to the highest standards of quality and our unwavering commitment to meeting the needs of patients globally," a company spokesperson said.
Last week, Biocon had informed the stock markets that the US health regulator had issued four observations after inspecting its Andhra Pradesh-based manufacturing plant.
The US Food and Drug Administration (USFDA) completed the GMP inspection of the Company's API facility (Site 5) located in Visakhapatnam, Andhra Pradesh on June 21, 2024.
Biocon shares were trading 0.54 per cent lower at Rs 343.75 on BSE.
