Aurobindo Pharma Ltd APL said in a regulatory filing that it received a warning from the capital markets regulator Sebi for non-disclosure of details related to an ongoing audit of one of its manufacturing units in Hyderabad and the US Food and Drug Administration USFDA.
The Sebi warning letter noted that the company had ''disclosed very limited and restricted information' and did not disclose the detailed reasons and did not consider the observations of the USFDA as serious, it added.
APL disclosures related to Official Action Indicated OAI and a warning letter issued by the USFDA to the company on June 24th, 2022 relate to the disclosures made by the company on August 24th, 2021 on the Unit I, an API active pharmaceutical ingredients manufacturing facility in Hyderabad.
The inspection conducted at its Unit I between August 2 and August 12, 2021, was classified as the OAI by the USFDA, but it would not affect the continuing commercial supplies to the US market from this facility, the Sebi letter said.
APL said on January 14, 2022 that the company received a warning from the USFDA for the unit I, with regard to the OAI classification of Unit I.
The company disclosed very limited and restricted information from the disclosures made by the company. A warning letter was received from the USFDA. The company did not reveal the details on the reason and the non-compliance aberration observed for which the warning was issued, the Securities and Exchange Board of India Sebi said in the letter.
The markets regulators also pulled up the pharma company for claiming that the information about the USFDA action was disclosed in investor's earnings call, the transcript that was disclosed on stock exchanges, even though it did not provide any additional information beyond what was already disclosed, according to Sebi, who said APL had submitted to the USFDA that it was not satisfied with the response of the company on two of the observations issued in the inspection, for which a warning was issued in January 2022.
The concerns raised by USFDA have already been addressed and status of corrective actions being updated constantly to the USFDA, and the two observations were not considered serious by APL, which claimed it had already taken robust corrective actions to mitigate the risk.
APL's submission on not considering the warning as serious is not tenable. The warning letter is available on the USFDA website, but the company chose to make limited disclosure. Sebi said that disclosure of the USFDA warning letter is insufficient and an impediment to assess the current status.
Sebi warned that the company had to ensure compliance with all applicable provisions of regulations because of the non-compliance by APL. Sebi asked the company to place its letter before APL's next board meeting and distribute the same to the stock exchanges if any such abbreviation was taken seriously and appropriate action would be initiated, Sebi said.