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| Exchange Disseminated Time 21/02/2017 07:57:45 | Glenmark Pharmaceuticals Ltd vide its letter dated February 20, 2017 has informed BSE about the following :
"We have received today a query from the media regarding Glenmark receiving the observations on its Ankleshwar Plant in Gujarat pursuant to the USFDA Audit.
Our response which will be sent to the media agency is given below:
"The API plant at Ankleshwar, India was inspected by the USFDA in December 2016. We received four observations from the FDA via the Form 483. We responded to the observations in January 2017. At this point in time, we have no outstanding items with the USFDA regarding this plant. The Form 483 is an integral part of the inspection process which is used to communicate inspection observations by the USFDA after it audits the manufacturing facility."" |
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