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 in a US FDA
inspection in April. These pertained to incomplete batch records, improper storage of drugs
and inadequate powers to quality control unit.
This is the second plant to clear regulatory hurdle after Mohali, which was cleared of an import alert in March.
The Street is looking forward to the resolution of GMP
deficiencies at the Halol plant, which contributes to around 10 per cent of its sales.
The US FDA
inspected the Halol plant
last November and had issued nine observations. Sun Pharma
Managing Director Dilip Shanghvi had said the company had completed all the remediation steps and was awaiting reinspection.
The firm’s stock closed at Rs 525.80, down 0.28 per cent, on the BSE.
The announcement came post the market hours.