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Divis Labs files response to USFDA observations

NEW DELHI, Jan 9:  Divis Laboratories today said it has filed a detailed response within the permitted time to the observations made by the US health regulator after inspection of the drug firm’s manufacturing plant at Visakhapatnam in Andhra Pradesh.
“The company has already filed its detailed response to the ‘Form 483’ observations of the USFDA within the time permitted,” Divis Laboratories said in a regulatory filing.
Last month, the US health regulator had made five observations after inspection of the company’s manufacturing plant at Visakhapatnam.
Divis Laboratories set up its second manufacturing facility at Visakhapatnam (Unit-II) in 2002 on a 350-acre site.
The site has 14 multi-purpose production blocks. The company manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at the plant.


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