Tag: BIOCON

Syngene International Ltd, the contract research unit of Biocon, announced the resignation of its chief operating officer Manoj Nerurkar. It said Nerurkar, who has been with the COO of the […]

Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP […]

Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in […]

The United States’ Food & Drug Administration has issued a Form 483 after inspecting Biocon’s Malaysia manufacturing plant, indicating that it found discrepancies during the inspection. Issue of Form 483 […]

Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab. “Mylan anticipates potentially being the first company […]

Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions. […]

Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India. The biosimilar — or a drug that mimics a natural […]

Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their […]

The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. […]

Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident. “US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility […]

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar […]

Mylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat […]

Biocon Ltd said it has received European approvals for generic versions of AstraZeneca’s cholesterol drug Crestor, opening up a billion dollar market. The approval has been obtained for Rosuvastatin Calcium […]

Syngene International, an India-based Contract Research Organisation and a subsidiary of Biocon Ltd, announced that it has received the Foreign Investment Promotion Board (“FIPB”) approval for raising the foreign investment […]