Aurobindo Pharma unit VII gets OAI from USFDA

However, the company said it will work closely with the drug regulator to comprehensively address the issues. (Representative image)Aurobindo Pharma has said that the drug regulator US Food and Drug Administration (USFDA) has cautioned that its oral solids formulation manufacturing facility in Telangana may be subject to regulatory actions.However, the company said it will work closely with the drug regulator to comprehensively address the issues.“Further to our intimations, with regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI),” the company said in a filing to BSE.According to USFDA reference, OAI means “objectionable conditions were found and regulatory administrative sanctions by FDA are indicated” during inspections. The company said it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.Aurobindo Pharma’s unit VII manufactures non-penicillins, non-cephalosporins and anti-retroviral medicines. The Unit VII is an oral solid dosage facility. The USFDA had inspected the facility in October 2019 and issued seven observations. The plant accounted for about 20% of the company’s US sales in FY19. It has 137 approved abbreviated new drug applications (ANDAs) and 32 pending ANDA approvals.Get live Stock Prices from BSE and NSE and latest NAV, portfolio of Mutual Funds, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

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