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Last Updated : Jul 10, 2017 10:29 AM IST | Source: Moneycontrol.com

Biocon cracks over 9% as French regulator finds lapses at Bengaluru plant

The ANSM raised 35 deficiencies, including 11 major deficiencies, concerning biosimilar products.

 
 
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Shares of Biocon tanked around 9.5 percent intraday on Monday as investors turned cautious of regulatory issues for the company.

The French drug regulator found lapses at Biocon's Bommasandra facility in Bengaluru with respect to good manufacturing practices (GMP) for activities related to three biosimilar products.

The French National Agency for Medicines and Health Products Safety, known as ANSM, inspected the Biocon's Bengaluru plant on behalf of the European Medicine Agency (EMA) between March 13 and March 17.

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EMA was reviewing Biocon's three biosimilar products — Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin Glargine) — for marketing authorisation in European Union.

The ANSM raised 35 deficiencies, including 11 major deficiencies, concerning biosimilar products.

Moneycontrol verified a copy of the non-compliance report (NCR) posted on EMA website.

The French regulator found GMP deficiencies, environmental monitoring-training, OOS (out-of-specification) results management, cleaning validation, process validation, vendors' qualification, media fill test, cross contamination risks, batch manufacturing record, differential pressure alarms' management in classified areas, and access management in SAP for batch certification.

The stock fell nearly 4 percent in the past one month, while its three-day loss stood at over 5 percent. At 09:43 hrs Biocon was quoting at Rs 320.60, down Rs 16.45, or 4.88 percent on the BSE. It touched an intraday high of Rs 336.00 and an intraday low of Rs 305.00.

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First Published on Jul 10, 2017 09:50 am
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