Gujarat-based Cadila Pharmaceuticals has recently received a warning letter from the US Food and Drug Administration over not complying with the current good manufacturing practice (CGMP) for production of active pharmaceuticals ingredients (APIs) at its Ankleshwar, Gujarat, facility.
The US regulator said it may withhold approval of any new drug using APIs manufactured from the facility and also issue an import alert on Cadila's products in the US market.
The regulator said it had inspected the facility during March 24-28 this year where it has identified "significant deviations". FDA also conducted a detailed review of Cadila's response dated April 10 and noted it lacked sufficient corrective actions.
FDA said the unit has several manufacturing issues and has indicated presence of more than allowable number of impurities on multiple occasions which had not been adequately investigated.
In its warning letter, dated October 15, to Rajiv Modi-owned Cadila Pharma, FDA said numerous stability samples have not been tested at the required intervals.
"Specifically, the inspection found that your 2014 stability programme was in backlog and that samples were overdue for testing. In addition, we are concerned that your quality unit was not aware of this backlog situation," it said.
Cadila was asked to send its response within 15 working days of the receipt of the letter.
"This is a repeat deficiency from our 2012 inspection, which also identified a large stability sample backlog. Your 2012 investigation failed to address the impact of the delayed sample testing on your known typical impurity profile," the letter said.
Cadila Pharma, in an email response to dna, said, "We at Cadila Pharmaceuticals are following up with the US FDA on all their queries, and are in the process of complying with all their requirements and addressing whatever issues raised by them. We have always maintained the highest global level quality at all our manufacturing plants and will ensure that these best of standards are always maintained."
Cadila Pharma is the latest one to join the list of Indian companies such as Ranbaxy, Wockhardt, Strides Arcolab and Sun Pharma, who have come under the US regulator's scanner over compliance issues related to manufacturing practices.
