MUMBAI: Aurobindo Pharma (APL) shares fell 1 percent after Sebi pulled up the company for making inadequate and timely disclosures on a USFDA warning letter. The company’s shares closed in the red on a day all sectoral and benchmark indices ended in the green.
It informed the exchanges on Nov 10 last year about receiving an Official Action Indicated (OAI) classification from the USFDA for Unit I, a manufacturing facility in Hyderabad for pharma ingredients. In its corporate announcement, APL said the OAI would not impact commercial supplies to the US market from the facility. OAI implies the US regulator can recommend administrative actions.
On Jan 14, 2022, APL disclosed to bourses that USFDA had issued a warning letter to it on the said unit. The company, in response to Sebi warning, said the USFDA was not satisfied with its response on 2 of the observations issued in the inspection, for which a warning letter was issued in Jan 2022.
Sebi noted the two observations issued by USFDA were not “considered serious” by APL. “…it was observed the company had disclosed very limited information. Only fact disclosed was that a warning letter was received from USFDA.”