Mumbai: Sun Pharmaceutical Industries Ltd has announced that it has received the Establishment Inspection Report (EIR)
from the USFDA for the inspection conducted at its Halol facility during the period February 12-23, 2018.
The drug regulator concluded that the inspection is now closed and the issues contained in the Warning Letter issued in December 2015 have been addressed.
Sun Pharmaceutical Industries advanced to Rs 560.75 on BSE, but has now declined to Rs 549.60, up 1.7% from its previous closing price.
Sun Pharma Managing Director Dilip Shanghvi said, “This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally.”
Last week, the stock exchanges had sought clarification from the company, after a section of the media quoted "No re-inspection at Sun Pharma's Halol unit." The stock spurted nearly 10% intraday Friday, June 8, 2018.
Sun Pharmaceutical Industries responded by saying that the USFDA classified the inspection of the company's Halol facility in Gujarat, India, as VAI (Voluntary Action Indicated) status, and that the company was awaiting the receipt of the Establishment Inspection Report (EIR) from the regulator for the above referred GMP inspection that took place from February 12-23, 2018.
Sun Pharma's Halol facility faced some tough moments in the past few years. The USFDA inspection in September 2015 saw the regulator issuing Form 483 with as many as 23 observations on plant.
A year later, the drugmaker got a warning letter with six observations, from the Americal drug regulator. In the following year, in December 2017, to be precise, the U.S. drug regulator issued Form 483 with nine observations.
The drug regulator started re-inspection of the Halol plant in the second week of February and subsequently awarded " Voluntary Action initiated status to the company, on February 12.