New Delhi: Ipca Laboratories said the USFDA warning letter involving its three facilities in India was for “withdrawal of exemption” on certain drugs as the shortage situation in the American market has changed.
The company said its representatives got in touch with the US Food and Drug Administration (USFDA) to know the reasons behind the recent issuance of warning letter to the company’s three plants at Pithampur, Silvassa and Ratlam. “USFDA clarified that the reason for issuing these letters is for withdrawal of exemption on certain drugs which was due to the change in drug shortage situation in the US market,” Ipca Laboratories said in a regulatory filing.
The USFDA has not carried out any new inspection or re- inspection of the company’s above manufacturing units, Ipca said. The company had however announced last week that all drugs made at its facilities at Pithampur, Silvassa and Ratlam have been banned from the US market.
It had said at that time that USFDA has taken the action after finding products manufactured at the three sites not adhering to current good manufacturing norms. The USFDA has refused admission to all drugs made at the company’s Pithampur and Silvassa facility, it had said.
All drugs except API Chloroquine Phosphate made at Ratlam (Madhya Pradesh) unit have also been denied entry in the US.
The ban on all drugs made at Pithampur (Madhya Pradesh) and Silvassa (Dadra and Nagar Haveli) will continue “until the company can demonstrate that the drugs manufactured from these manufacturing sites and intended for the US market are in compliance with cGMP,” Ipca Laboratories had said last week.