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Biocon to address French regulator concerns in a quarter: Mazumdar Shaw

Firm to take remedial steps at its unit, get it inspected again in order to obtain GMP certification

Raghu Krishnan  |  Bengaluru 

Kiran Mazumdar-Shaw
Kiran Mazumdar-Shaw. Photo: Kamlesh Pednekar

Kiran Mazumdar Shaw, chairman and managing director of says that India's largest Biopharma company will take remedial measures at its drug product facility within a quarter and ask the French medical regulator to inspect its facility again to get certified for good manufacturing practice (GMP).

has filed for regulatory approvals to market its =- Trastuzumab and Pegfilgrastim, in the highly regulated European market with the (EMA). French National Agency for Medicines and Health Products Safety or conducted the mandatory site inspections on behalf of EMA as part of its pre approval procedures.

"There are no data integrity issues and no product quality issues. The concerns that they have expressed, we are taking remedial measures in short time, within a quarter and as soon as we are ready, we will ask them for a re-inspection," said Shaw. "There will be no material impact"

had conducted audits in March and approved GMP compliance certificate for two drug substance facilities and insulin Glargine pen facility.

However, it had recommended corrective steps to be taken in the drug product facility, where the drugs are produced for export, said in its filings on Sunday.

is looking to enter the highly regulated European and US markets with its by next fiscal. For this, it had filed marketing authorization application with the European regulators. In February, its joint Biologics License Application with Mylan for was accepted by the US Food and Drugs Administration (FDA).

stock had closed Rs 15.80 or 4.69 per cent down at Rs 321.25 on the Bombay Stock Exchange on Monday. (EOM)

 

First Published: Mon, July 10 2017. 19:08 IST
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