Fermenta Biotech receives EU GMP Certification for its Dahej facility
This approval reflects company’s unwavering commitment that the quality assurance
This approval reflects company’s unwavering commitment that the quality assurance
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The facility will manufacture its Herceptin biosimilar, Tuznue
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