Aurobindo tanks on FDA warning to unit

Aurobindo Pharma shares tanked almost 7% intraday on Thursday on the back of the U.S. Food and Drug Administration (USFDA) issuing a warning letter to the oral solid manufacturing facility of subsidiary AuroLife Pharma in New Jersey, U.S. The shares ended the day 2.84% lower at ₹782.45.

Stating that the subsidiary had received a warning letter from the USFDA, the firm said that in June the regulator had issued an Official Action Indicated status for the facility. “The existing business from this facility will not be impacted,” Aurobindo Pharma said in an exchange filing.

Aurobindo shares recovered from the intra-day low of ₹749.55 apiece, a decline of 6.92% from the previous close of ₹805.30, to end the day 2.84% lower at ₹782.45.

In June, the company had said on conclusion of an inspection of the AuroLife Pharma facility in Dayton, New Jersey, from January 13 to February 12, the USFDA had issued a Form 483 with 9 observations. The regulator classified the inspection as OAI.

The company said that the OAI classification may not have any material impact on existing revenues, the supplies of its U.S. business or pipeline products at this juncture. The exclusive sales from this facility is about 2% of the group turnover, Aurobindo Pharma said.

In a separate development, Aurobindo Pharma said it had received final approval from the USFDA to manufacture and market Acetaminophen Injection, 1,000 mg/100 mL single-dose vial (SDV). A generic equivalent of Mallinckrodt’s Ofirmev Injection, the product will be launched in December. Acetaminophen Injection is indicated for the treatment of mild-to-moderate pain in adult and pediatric patients 2 years and older.

The approved product has an estimated market size of $339 million for the 12 months ended August 2020, the company said, referring to IQVIA numbers. This is the 75th ANDA to be approved out of Unit IV formulation facility in Hyderabad used for manufacturing injectable and ophthalmic products, a release said.

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Printable version | Sep 24, 2021 3:11:33 PM |

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