Mumbai-based Cipla Ltd. on Wednesday said it has received observations from the United States Food and Drug Administration for its Goa manufacturing facility.
It further said that the developments will not have any material impact on the company's U.S. business at this stage.
"This audit got completed in September and while this classification has been submitted to us yesterday, we have already been on the job", Cipla Joint President and Global Chief Financial Officer Kedar Upadhye told BloombergQuint in an interview, adding that the company has been working with the U.S. FDA in a collaborative manner.
The company had sent a detailed response to them in October and a response is due in the next few weeks, he said.
Cipla further said it has a strong track record of maintaining the highest standard of compliance and will work closely with the agency to comprehensively address the observations received.
With inputs from PTI
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