SEBI warns Aurobindo Pharma over USFDA audit

Market regulator Securities and Exchange Board of India (SEBI) has issued a warning letter to Aurobindo Pharma for disclosing “very limited and restricted information” to the stock exchanges about an USFDA audit of the company’s active pharmaceutical ingredients manufacturing facility (API) in Hyderabad, the company revealed on Monday.

“The only fact disclosed was that a warning letter was received from the U.S. FDA. The company did not disclose details on the reason and the non-compliance/aberration observed,” SEBI said. The disclosure is not in line with principles governing disclosures and obligations of listed entities, it said.

“You are hereby warned and advised to ensure compliance with all applicable provisions of SEBI Regulations. Any such aberration in future would be viewed seriously and appropriate action would be initiated,” the regulator said in the letter.

Meanwhile, the company said the SEBI communication pertains to certain disclosures made on the ongoing USFDA audit of the company’s Unit-1 and observations made by the USFDA between 2019 to 2022.

According to reports, the pharma firm was criticised by SEBI for asserting that information on the USFDA action was given in the investor’s earnings call, whose transcript was made public on stock exchanges although it “did not provide any additional information beyond what was already disclosed”.

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