The U.S. Food and Drug Administration (FDA) has banned imports from two facilities operated by Indian pharmaceutical company Ipca Laboratories Ltd.
The agency said that generic drugs produced at Ipca's plants in Pithampur and Silvassa were now subject to an import alert because the facilities did not comply with standard drug manufacturing practices. Details of why the FDA reached this conclusion were not released.
In a stock exchange statement, Ipca said that following an earlier inspection of its active pharmaceutical ingredients (APIs) production unit at Ratlam in Madhya Pradesh, FDA officials visited the company's formulations manufacturing units in Pithampur and Silvassa and issued their inspection observations in a Form 483.
This document sets out investigators' concerns over conditions or practices observed at the facility.
"We now wish to inform you that the U.S. FDA has issued import alert to the company's said formulations manufacturing units situated at SEZ Indore (Pithampur) and Piparia (Silvassa) on March 24, 2015," the company stated.
India's pharmaceutical sector, a major supplier to the U.S. market, has faced increased scrutiny by the FDA over the past two years. Several manufacturers have faced sanctions over issues ranging from hygiene levels to concealing data on failed tests, Reuters reported.
Commenting on the latest action by the U.S. regulator, Ipca pledged to get its plants FDA-compliant as soon as possible so that it can fully resume exports to the United States.
"The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture," Ipca stressed.
