Dr Reddy’s rises 3%; USFDA says Duvvada unit status unchanged



Shares of Dr. Reddy’s Lab gained 3% after the company said it got an Establishment Inspection Report (EIR) from USFDA for its Duvvada plant.

However, in cover letter to the EIR, FDA has explained that the inspection has not closed, and the site’s status remains unchanged, but the FDA has released the EIR in order to be transparent about its regulatory process.

The stock had surged nearly 10% intraday as the US FDA gave the unit an establishment inspection report.

Dr Reddy's plans to request the US FDA to re-inspect the unit in 2018.

Also, the company had received a warning letter from the USFDA in November 2015. The U.S. regulator further made 13 observations for its Duvvada oncology formulation facility on March 9, 2017. The plant contributes to less than 10% of its entire revenue but manufactures two key oncology drugs.

The stock is currently trading at Rs 2349.5, up by Rs 72.2 or 3.17% from its previous closing of Rs 2277.3 on the BSE. The scrip opened at Rs 2280 and has touched a high and low of Rs 2498 and Rs 2277.3 respectively.

Dr. Reddy's deals in pharmaceutical services and active ingredients, global generics and proprietary products. It derived 66% of FY17 revenues from export formulations, followed by domestic formulations (16%), APIs (15%) and others (3%). The company’s key markets include India, USA, Russia and Germany.




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