Indian Drugmaker’s Products Banned from U.S. Market after Drug Shortage Ends

The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S.

The drugmaker acknowledged the U.S. import ban, instituted in 2015, in a series of filings this week with the Bombay Stock Exchange, but clarified that the company’s manufacturing facilities have not recently been re-inspected by the FDA.

Only the company’s malaria treatment API — chloroquinine phosphate, manufactured at the Ratlam plant — is currently exempted from the ban and “will be reconsidered if shortage and/or medical necessity implications change,” according to the company’s BSE filing. — Gayle S. Putrich