US Food and Drug Administration continues ban on Sun Pharma's Gujarat plant

MUMBAI: The US Food and Drug Administration has continued its import ban on Sun Pharma's Karkhadi plant in Gujarat.

The US drug regulator had issued a warning letter to Sun Pharma in March this year for not complying with the goods manufacturing norms practice. However, the recent inspection by the FDA found that Sun Pharma has not plugged the gaps which was raised while issuing the warning letter.

“We have conducted a detailed review of your firm’s initial response and note that it lacks sufficient corrective actions”, said Joseph Duran, Compliance Officer US Food and Drug Administration in a letter to Sun Pharma.

“Your response is inadequate in that your investigation was primarily limited to the discarded CGMP records... The investigation did not include a comprehensive review of all records in the waste area or a thorough review of your firm’s practice of destroying CGMP records”, the letter further added.

Sun Pharma has 15 days time to reply to the various concerns raised by the FDA related to the plant.

Sun Pharma couldn't be reached for a comment.

On Tuesday, Sun pharma's shares closed at Rs 587 down by 0.63%.