USFDA conducts inspection at Biocon’s Bengaluru facility

United States Food and Drug Administration (USFDA) has conducted a pre-approval inspection of Biocon’s new Oral Solid Dosage Forms manufacturing facility at Bengaluru from November 05 to 09. The audit concluded without any observations and no Form 483 was issued. Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals … Read more

Biocon features in top global pharma & biotech employers list 2018

Biocon has moved up in the Top 10 Global Biotech Employers ranking for 2018 and continues to be the only company from Asia to feature on the prestigious U.S.-based Science magazine’s annual ‘Science Careers Top 20 Employers’ list, since its debut in 2012. Ranked at No. 7 amongst global pharma and biotech companies in 2018, … Read more

Biocon, Mylan N.V. receive positive CHMP opinion for Ogivri

Biocon and Mylan N.V. have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab). The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in … Read more

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