US FDA clears Sun Pharma's Dadra plant

Dadra is Sun Pharma's second-largest plant in India, and had received 11 adverse observations in a US FDA inspection in April

The US Food and Drug Administration (US FDA) has cleared Sun Pharmaceutical Industries’ Dadra plant paving the way for product approvals from the site. The drug maker notified the BSE on Wednesday that the US FDA had issued an establishment inspection report, indicating the resolution of good manufacturing practices (GMP) deficiencies at the plant.

The US business contributes nearly half of Sun Pharma’s revenue, which has come under pressure due to price erosion and regulatory troubles. The company reported net sales Rs 31,308 crore in 2016-17.

Dadra is Sun Pharma’s second-largest plant in India, and had received 11 adverse observations