In a regulatory filing today, Cadila Healthcare said the Company has received a warning letter issued by the United States Food and Drug Administration (USFDA) relating to its Moraiya formulation facility.
However, the drug maker added the warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue.
The company said it has taken multiple steps after the inspection to address the observations received from USFDA during the inspection. The management is confident of responding to USFDA to address the observations within the statutory time permitted in the letter.
After the inspection of Moraiya facility, Zydus Cadila has successfully completed USFDA audits of formulations manufacturing facility at Baddi, and API manufacturing facilities at Ankleshwar and Dabhasa during the year.
At 02:48 pm, the stock was trading 5 per cent lower at Rs 244 on the BSE, as compared to a 0.46 per cent rise in the S&P BSE Sensex. The trading volumes on the counter jumped more than six-fold with a combined 4.86 million shares changing hands on the NSE and BSE so far.