New Delhi: Biotechnology main Biocon on Friday stated the Bengaluru-based plant of Biocon Biologics has obtained EU GMP approval for a biosimilar product.
Biocon Biologics’ facility has obtained a certificates of GMP compliance for Bevacizumab from the consultant European inspection authority — Health Products Regulatory Authority (HPRA), Ireland.
Bevacizumab is indicated for the therapy of assorted forms of cancers and particular eye ailments. “This approval reflects Biocon Biologics compliance with the highest international regulatory standards and enables the company to continue addressing the needs of patients in the EU,” an organization spokesperson stated in a press release.
This (B3) facility, which is considered one of India’s largest monoclonal antibodies (mAbs) manufacturing amenities, had obtained the EU GMP Certification for manufacturing biosimilar Trastuzumab final 12 months, the spokesperson stated. Biocon Biologics is a subsidiary of Biocon Ltd.
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