Sun Pharmaceutical Industries Ltd. said Tuesday that its wholly owned U.S. unit, Sun Pharmaceutical Industries Inc., received a warning from the U.S. Food and Drug Administration related to manufacturing practices at a facility, making it the second instance of U.S. regulatory action against the Indian drug maker's U.S. units.
The Indian company suffered a profit decline in the last financial year as sales in the key U.S. market were hurt after the FDA found drug-manufacturing defects in 2009 at another U.S. unit, Caraco Pharmaceutical Laboratories Ltd. The FDA seized some drugs made by the U.S. unit at its facilities in Michigan and Caraco had to stop production there.
Sun Pharma said the warning letter to Sun Pharmaceutical Industries Inc. was issued as a follow-up to the last inspection of the unit's manufacturing facility at Cranbury, N.J., initiated in February. The FDA had identified violations of current good manufacturing practice regulations during the inspection, the statement added.
Sun Pharma said its unit has undertaken immediate corrective action. Sun Pharmaceutical's unit intends to respond promptly to the FDA within 15 working days, the statement said, adding it is committed to cooperating with the U.S. drug regulator to resolve the matters. The company warned that until its unit is able to satisfy the FDA with its responses, the regulator may in the near term withhold approval of pending new drug applications listing the Cranbury facility as the manufacturer.
Sun Pharma said it is maintaining its consolidated sales growth outlook for the current financial year that started April 1. The company had in May predicted sales growth of 18%-20% from last year.
(Source: The wall street journal)
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