Sun Pharma’s Halol facility went under USFDA’s import ban in 2015 as the regulator found that the drugmaker’s manufacturing plant had violated the good manufacturing practice of the regulator

 

The US Food and Drug Administration has lifted the ban from Sun Pharma’s  Halol manufacturing plant in Gujarat. A two-year import ban was imposed on Sun Pharma by USFDA over quality control issues.

“This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24×7 Current Good Manufacturing Practice compliance at all our manufacturing facilities globally,” said Dilip Shanghvi, MD, Sun Pharma. The USFDA’s Establishment Inspection Report (EIR) comes days after the company received Voluntary Action Indicated (VAI) that indicated that clearance for the plant wasn’t too far away. Last week, Sun Pharma share jumped by 8% to a 10-month high as the news of its VAI hit the markets.

Sun Pharma’s Halol facility went under USFDA’s import ban in 2015 as the regulator found that the drugmaker’s manufacturing plant had violated the good manufacturing practice of the regulator. The regulatory action forced the company to lose out on key product launches. Sun Pharma lost 14% of its market cap in the past two years, prompting several brokerage houses to downgrade the stock.

Comments