Aurobindo Shares Tank On USFDA Observations

Drugmaker Aurobindo Pharma shares declined 8.73% on Thursday after the company’s general injectable formulation manufacturing facility in Pashamylaram here received 14 observations from the US Food and Drug Administration (USFDA).

The Rs 395.55 at which the scrip closed the day was a semblance of recovery as during intra-day the share had touched a 52-week low of Rs 389.70.

The fall came after the company, on Wednesday, said the USFDA, on conclusion of an inspection of the Unit IV general injectable formulation manufacturing facility from November 4-13 had issued a Form 483 with 14 observations.

“We believe that none of these observations is related to data integrity issues. The company will respond to the USFDA within the stipulated timeline,” Aurobindo Pharma said in a filing. But that seems to have made little difference with the share opening the day at Rs 414 each as compared to the previous close of Rs 433.40.

According to Emkay Global Financial Services, the facility is the company’s key injectable formulations plant and has around 47 pending filings or about 30% of the overall filings.

“The sheer number [of observations] is on the higher side and likely to keep investors nervous until details emerge,” Emkay said.

According to its assessment, the Unit IV accounted for 9-10% of US sales and 8-9% of overall EBITDA in FY19. It accounts for 50-60% of total injectable sales ($213mn in FY19), with the rest being from Unit XII, Eugia and Auronext facilities. – The Hindu

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