Shares of Aurobindo Pharma dipped 5 per cent to Rs 448, in otherwise firm market, on the BSE on Wednesday after the US health regulator (US FDA) issued ‘Form 483’ with four observations for its Hyderabad facilities. The stock of the drug firm was trading close to its 52-week low of Rs 435 touched on October 11, 2019 in the intra-day trade.
“The United States Food and Drug Administration (US FDA) inspected Unit V, API manufacturing facility at Pashamylaram, Hyderabad and Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad of the Company from 21st to 28th October 2019 and from 21st to 25th October 2019, respectively. At the end of the inspections, we have been issued a 'Form 483' with 4 observations for each facility,” Aurobindo Pharma said in a regulatory filing. READ HERE
The management believes that these observations are related to procedural improvements and none of the observations are related to data integrity. The company will be responding to US FDA as per the prescribed time lines, the statement said.
With respect to Unit IV, formulation manufacturing facility at Pashamylaram, Hyderabad, the inspection is in progress. USFDA audit is an activity under the normal course of business in the pharmaceutical industry, it added.
Earlier on October 7, Aurobindo Pharma had received Form 483 for the much-awaited Unit VII inspection with seven observations.
The delay in Sandoz deal closure, OAI/WL on the three API facilities and Unit VII Form 483 has meant de-rating in the stock reflected in the correction from Apr-2019 peak. The stock has slipped 45 per cent since its April 2019 peak, while the benchmark S&P BSE Sensex gained 5 per cent during the period.