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The wait for the investors of Sun Pharma is finally over with the Halol plant getting a clearance. This facility has received a Voluntary Action Indicated (VAI) status from the US drug regulator.

Halol is critical to Sun Pharma’s US business and has been under the warning letter since 2014.

Sun Pharma received 23 observations in September 2014 following which it received a warning letter in December 2015. In the December 2016 audit, USFDA found nine observations while in the re-inspection in February 2018, this plant received three minor observations. The three observations were not related to Data integrity and hence there was a high probability of the resolution of the regulatory issues without an inspection.

The Halol resolution would now pave way to start filling new products from this facility, which is also its largest facility. The resolution has also come at a time when Sun Pharma is battling to stop the slide in the US revenues. To grow its US generics business, company needed a large facility which can offset price erosion by selling higher volumes. Halol can help Sun Pharma in bringing additional volumes to the US market and investors will now start to seek information of ANDA pipeline from this plant from the management.

With Halol resolution, Sun Pharma, can now bring more competition in the US market. This may be negative for other generic pharma companies in the US.

This is also positive for Sun Pharma Advanced Research Company, which will now be able to get approval to its novel drugs filed from this facility.

Last modified on Friday, 08 June 2018

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