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Sun Pharmaceutical Industries’ Halol plant in Gujarat, is cleared by the Dutch health regulator. The Dutch Agency has given Good Manufacturing Certificate to Sun Pharma’s Halol unit.
The Halol unit was audited by the Dutch’s health regulator on August 25,2017. This clearance by the Dutch regulator might lead to an early approval from the US Food and Drug Administration for the same plant.
Furthermore, this plant is important to company’s big products approval and it had received a warning letter from the USFDA in December 2015, due to violation of good manufacturing practices. Therefore, the rate of product approvals in US has been slow.
