FDA Slaps Warning on Sun Pharma's Former U.S. Facility for Releasing Drug Despite Contamination Issues

The U.S. Food and Drug Administration has pulled up a former Sun Pharmaceutical drug factory for "knowingly" releasing 27 lots of the hypertension drug clonidine last year, despite proof that the raw materials used may have been contaminated.

This is one of a series of quality concerns tied to the Philadelphia, Pennsylvania factory that the FDA highlighted in an Aug. 15 "warning letter" issued to the site's current owner, U.S. firm Frontida BioPharm Inc.

The plant was sold to Frontida in June by Sun, India's No. 1 drugmaker, which said the move was "a part of its manufacturing consolidation in the U.S."

Back to news