Sun Pharma’s Mohali plant on FDA radar

Drug major Sun Pharmaceutical Industries recently said the US health regulator is conducting an inspection of its Mohali facility in Punjab. The three-day surprise inspection by the United States Food and Drug Administration (USFDA) started on September 10, 2018 and is ongoing, Sun Pharma said in a filing to BSE.

The company, however, did not provide any further details of the inspection.

In 2017, the US regulator had proposed to lift import alert on Mohali-based plant. The USFDA, in September 2013, had issued an import alert on drugs produced at the then Ranbaxy’s Mohali plant for violation of current good manufacturing practices. Last week, the USFDA had issued Form 483 with six observations after an inspection of the company’s Halol facility in Gujarat.

The US regulator FDA had conducted a pre-approval inspection (PAI) of the Halol plant in August, Sun Pharma had said in a regulatory filing.

Shares of Sun Pharmaceutical Industries today closed at INR 631.05 per scrip on BSE, down 1.32 per cent from its previous close.

-----------------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.