The news was not very good from Biocon. The company’s three products at its Bengaluru facility failed to comply with Good Manufacturing Practices (GMP) as per France’s health regulator ANSM.
The French regulator conducted its inspection between 13th and 17th of March and found concerns with sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit, only for the three products - Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin glargine).
This would now mean a delay in getting into the European markets as approvals are bound get delayed, could have implications for USFDA approvals too.
The company said that there were no critical observations in the final report and ANSM has said that a follow-up inspection will be required in order to receive a go-ahead certificate for the drugs.
The stock price tanked – from Friday’s close of Rs.337, it opened lower at Rs.328, going down to Rs.305. It has recovered from the days low but remains firmly in the red.