Biocon fell 5.09% to Rs 319.90 at 11:42 IST on BSE on reports that the French health regulator found lapses in quality compliance at its Bangalore plant during a March inspection.
Meanwhile, the S&P BSE Sensex was up 194.34 points or 0.62% at 31,554.97.
On the BSE, 6.49 lakh shares were traded on the counter so far as against the average daily volumes of 1.34 lakh shares in the past one quarter. The stock had hit a high of Rs 336 and a low of Rs 305 so far during the day. The stock had hit a record high of Rs 396 on 25 April 2017 and a 52-week low of Rs 229.66 on 19 July 2016.
The stock had outperformed the market over the past one month till 7 July 2017, advancing 1.27% compared with the Sensex's 0.29% rise. The stock had, however, underperformed the market over the past one quarter, declining 7.9% as against the Sensex's 5.57% rise. The scrip had outperformed the market over the past one year, surging 38.33% as against the Sensex's 15.29% rise.
The large-cap company has equity capital of Rs 300 crore. Face value per share is Rs 5.
In a stock exchange filing on Sunday, 9 July 2017, Biocon said the French inspecting authority (ANSM) conducted pre-approval inspection audits of the company's Bangalore drug substance and drug product sites related to the pending EMA Marketing Authorization Applications for Trastuzumab, Pegfilgrastim and related to Insulin Glargine (pen assembly only).
While there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation of the proposed corrective and preventive actions (CAPAs).
ANSM has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs. Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early re-inspection.
ANSM has issued GMP compliance certificates for Biocon's two drug substance manufacturing facilities in Bangalore. This is important as the drug substance manufacture is core to the production of the actual biologic product in GMP compliance, Biocon said in a statement.
On a consolidated basis, net profit of Biocon declined 61.7% to Rs 127.50 crore on 1.5% decline in net sales to Rs 919.20 crore in Q4 March 2017 over Q4 March 2016.
Biocon is India's largest and fully-integrated, innovation-led biopharmaceutical company.
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