Biocon: USFDA clears Telangana API facility

The biotech major's Active Pharmaceutical Ingredient (API) manufacturing facility located in Telangana was inspected by the USFDA in the month of December. The inspection concluded without any observation.

The US drug regulator did not issue a Form 183, thereby signalling a successful completion of the GMP inspection of the manufacturing plant.

On the drug development front, in November, Biocon and Mylan received EU approval for its biosimiliar Fulphila, which is used in the treatment of cancer. While Teva has recently received USFDA approval for its cancer drug trastuzumab, making it the second company after Biocon to get clearance for trastuzumab biosimiliar in the US market.

Meanwhile, on Monday the stock of Biocon Limited opened at Rs. 650 per share and at 9:54 hours, the stock was quoting Rs. 632.45 per share or down by 2.15 per cent, when the benchmark BSE Sensex was at 36,177.11, up by 214.18 points or 0.60 per cent and Nifty50 was at 10,857.65, up by 52.20 points or 0.48 per cent. The Nifty Pharma index was at 8,790.40 per share, up by 0.73 per cent, Glenmark was leading the index at Rs. 693.10 per share, up by 3.67 per cent, while Dr. Reddy, Aurbindo Pharma, and Cadila was up more than 1 per cent. Piramal and Biocon were the only stocks that were trading negative on the index.