Sanofi India Ltd has recalled its four batches of famous painkiller combination, after the Indian regulator found the product to be sub-standard.
“There is a pharmaceutical parameter that requires the breakdown of a tablet in the human body to be assessed. In the case of Combiflam, though the disintegration time was delayed, doctors and patients can be assured that there is no impact on the safety and efficacy of the product,” Sanofi said.
Combiflam, is a combination of paracetamol and ibuprofen, it is the second largest brand in the non-steroidal anti-inflammatory (NSAID) market, with sales of Rs.162.7 crore, for the last financial year.
The Drugs Controller General of India (DCGI) was already issued safety alert first in February and then again in April, after some batches of Combiflam were found not of standard quality due to delayed disintegration of the molecule in the blood stream.
The tablets were manufactured at Sanofi’s factory in Ankleshwar, Gujarat.
On the flip side, shares of Sanofi dropped 0.67% to Rs.4318.50 on BSE while the benchmark Sensex declined 0.68% to 25,597.02 points.