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FDA raising concerns about quality control at Sun Pharma plant

FDA

Once again, the Food and Drug Administration (FDA) has questioned the quality control systems of Sun Pharmaceutical Industries. These questions specifically relate to Sun Pharma’s plant in Halol, in the state of Gujarat, western India. Sun Pharma are an Indian pharmaceutical giant and the 5th biggest maker of generic drugs. Disputes with the FDA could seriously dent their ambitions of further growth.

Repeat offenders

Sun Pharma were informed of these issues, but details of exactly what violations occurred were still unknown. Now, the FDA have disclosed their concerns in a 14 page report, following inspections between November 17 and December 1.

What is most concerning however, is that some violations which were found during FDA inspections in 2015, have still not been rectified. Sun Pharma have taken steps to improve processes in the Halol facility, but are yet to reach the FDA’s standards.

The violations disclosed by the FDA after their latest examination at Halol include problems with the quality control process. These were the same concerns raised a year ago. Specifically, the FDA asserted that appropriate checks were not being made to assure that document changes relating to the drug making process were being carried out by authorized staff.

Further violations

The FDA also cited a lack of proper care when keeping records relating to the drug making process, with these records regarded as being extremely important. Furthermore, the FDA voiced concerns regarding how accurate their pharmaceutical testing methods are and also found delays from Sun Pharma in informing them when there were contaminations or failures of entire batches of drugs.

Can Sun Pharma improve?

It is crucial for Sun Pharma to gain FDA approval for their Halol facility as the US is their biggest market for generic pharmaceuticals. They have several drugs waiting for approval, and that can only happen once Halol has met all the FDA’s standards.

Sun Pharma have not yet made comments to the media regarding this matter. Shares in Sun Pharma have fallen dramatically during 2016, dropping around 17% of their value and the latest FDA report will not have improved matters. Time will only tell if they can bring Halol up to standard and grow their American penetration.

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Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.

 

CONTENT SPONSORED BY

 

WSGR_HORIZ_CMYK2

Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.

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