New Delhi, Jun 15 (PTI) Almost all drugs manufactured by Ipca Laboratories at its facilities at Pithampur, Silvassa and Ratlam have been banned from the US market by the country’s health regulator.
The US Food and Drug Administration (USFDA) cited violation of current good manufacturing norms for taking the step against the company.
The USFDA has refused admission to all drugs made at the company’s Pithampur and Silvassa facility, Ipca Laboratories said in a BSE filing.
All drugs except API Chloroquine Phosphate made at Ratlam (Madhya Pradesh) unit have also been denied entry in the US, it further said.
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 added.
However, it said the US health regulator will reconsider the exception for Chloroquine Phosphate made at the Ratlam facility, if shortage and/or medical necessity implications change.
Last year, the USFDA had issued warning letter to the company over violations of manufacturing norms at the three facilities.
Shares of Ipca Laboratories closed 0.86 per cent down at Rs 513.15 on BSE.
This is published unedited from the PTI feed.