The Indian pharma major Cipla on Thursday revealed in a regulatory filing that its Goa-based facility which was earlier inspected by USFDA in August this year continues to remain in the 'Official Action Indicated' (OAI) classification by the top US regulator.
Further to this, the company informed its shareholders that USFDA may withhold Cipla's product approvals till the current observations are not resolved.
"We wish to inform you that the Company has received a communication from the USFDA that the classification of Company’s said facility continues to be as Official Action Indicated (“OAI”). USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved," the company said in the regulatory filing.
Cipla also highlighted that the company has a plan in place for its new product clearances and the it will work towards addressing the issues with USFDA.
"The Company has an ongoing derisking plan in place for new product approvals. The Company will work closely with the USFDA and is committed to address these within the stipulated time," Cipla said.
The company's stock closed 1.10 per cent lower on Thursday at Rs 1,095 a piece on BSE.