Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat.
The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports.
Shares of Cadila Healthcare were down 5% at 244 after the news. They were treading at around Rs 345 in April-May.
“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,” it said.
The development comes barely three months after the FDA put the factory under ‘official action indicated’ status.
On May 3, it was revealed that inspectors from the US FDA had made 14 observations after an inspection at the plant that started on April 22.
Some of the observations noted by the inspectors include equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination.
“The Company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facility. We are confident of responding to USFDA to address the observations within the statutory time permitted in the letter,” the company said today.