Aurobindo trims losses after 3 US FDA observations

The observations are procedural in nature and we will respond to the USFDA within the stipulated timelines, company said in its release.

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Aurobindo Pharma shares recovered initial losses and traded marginally higher at Rs 780.60 at 9:43am after the company received three observations from the US Food and Drug Administration (USFDA).

The US FDA issued the Form 483 with three observations following inspection at Aurobindo Pharma‘s Unit III, a formulation manufacturing facility at Bachupally Village in Medchal Malkajgiri district of Telangana during July 14-21.

“The observations are procedural in nature and we will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest,” the company said in a statement.

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The USFDA also conducted an inspection at the company’s Unit XIV at Jawaharlal Nehru Pharma City in Anakapalli district of Andhra Pradesh, from May 15-19. The unit received establishment inspection report classifying the facility as voluntary action indicated (VAI), the company said on July 17.

On July 12, Aurobindo Pharma’s wholly owned subsidiary APL Healthcare received a final approval from the US regulator to manufacture and market Sevelamer Hydrochloride Tablets 400mg and 800mg, Sevelamer Hydrochloride Tablets 400mg and 800mg, to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Renagel Tablets, 400mg and 800mg, of Genzyme Corporation.