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USFDA clears Indoco Remedies' Goa plant

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Press Trust of India New Delhi
Drug firm Indoco Remedies Friday said the US health regulator has cleared its Goa-based manufacturing facility after concluding an inspection.
The US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of the company for finished dosages, Indoco Remedies said in a regulatory filing.
The health regulator had inspected the plant in November last year, it added.
"The change in the inspection classification status from 'Official Action Initiated' (OAI) to 'Voluntary Action Initiated' for Indoco Remedies by USFDA signifies that the site has come out of the warning letter issued to the site in March 2017," it said.
Several pending abbreviated new drug applications (ANDAs) from this facility will now be approved, it added.
Shares of the company Friday ended up 8.6 per cent at Rs 202.70 apiece on the BSE.

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First Published: Mar 29 2019 | 5:10 PM IST

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