Aurobindo Pharma spurted 15.07% to Rs 622 after US drug regulator classified the company's Unit IV of Hyderabad plant as VAI (voluntary action indicated).
"Further to our intimations dated 13th November 2019, 19th February and 21st February 2020 with regard to the inspection of Unit IV, an injectable manufacturing formulation facility of the company, conducted between Nov 4th-13th, 2019, we would like to inform that USFDA has determined that the inspection classification of this facility is Voluntary Action Indicated (VAI)," Aurobindo Pharma announced after market hours on Monday (20 April).In November 2019, Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) inspected the company's unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad, from 4th to 13th November 2019. At the end of the inspection, it issued a 'Form 483' with 14 observations.
Later on 19 February 2020, the drug maker informed that the Hyderabad facility received an Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) status from USFDA.
However on 21 February 2020, Aurobindo Pharma clarified that the inspection conducted by the USFDA at the company's Unit IV of Hyderabad facility, from 4th to 13th November 2019 was still open and under review, by way of rescindment of 90-day VAI letter that was issued by them on 18 February 2020.
On a consolidated basis, the drug maker's net profit declined 0.95% to Rs 705.45 crore despite 12.06% rise in net sales to Rs 5,799.44 crore in Q3 December 2019 over Q3 December 2018.
Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs). Its product portfolio is spread over seven therapeutic/product areas, including antibiotics, anti-retrovirals, cardiovascular, central nervous system, gastroenterologicals, anti-allergies and anti-diabetics.
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