After opening the day in green, Share markets in India witnessed selling pressure and are presently trading in red. Sectoral indices are trading on a mixed note, with stocks in the IT sector and stocks in the telecom sector witnessing maximum buying interest. While stocks in the pharma sector are leading the losses.
The BSE Sensex is trading down by 160 points (down 0.5%) and the NSE Nifty is trading down by 45 points (down 0.4%). Meanwhile, the BSE Mid Cap index is trading down by 0.8%, while the BSE Small Cap index is trading down by 0.5%. The rupee is trading at 64.84 to the US$.
In news from stocks in the pharma sector. Biocon share price is in focus today after its partner Mylan N.V. has resubmitted marketing authorization applications for two of its products to the European Medicines Agency (EMA).
Mylan resubmitted applications for two biosimilars-trastuzumab and pegfilgrastim-with the EMA that were withdrawn in August due to quality compliance issues at Biocon’s manufacturing plant.
In March, Biocon’s drug substance and drug product sites in Bengaluru were inspected by French National Agency for Medicines and Health Products Safety on behalf of the EMA. The inspection was related to Biocon’s pending marketing authorization applications for biosimilars trastuzumab and pegfilgrastim as well as for insulin glargine.
While the French regulator issued good manufacturing practices (GMPs) certificates to the company’s two drug substance manufacturing units, it found quality lapses in the drug product unit.
Biocon has completed the corrective and preventive actions, including the facility modifications, in response to the audit observations and expects these to be verified during re-inspection.
The company will get GMP compliance certificate for the drug product facility only after a follow-up inspection by EMA to verify the implementation of the corrective and preventive actions for the plant.
