Cipla gets US FDA warning letter over Goa facility

The Mumbai-based firm also said it remains committed to maintain highest standards of compliance and will work closely with FDA to comprehensively address all the observations.
An employee works at the reception area of Cipla at its headquarters in Mumbai (File photo| Reuters)
An employee works at the reception area of Cipla at its headquarters in Mumbai (File photo| Reuters)

HYDERABAD:  Drug firm Cipla Ltd on Wednesday said the US health regulator has issued a warning letter to the company for its manufacturing facility in Goa for serious violations of good manufacturing practices observed during an inspection last September. A warning letter implies breach of good manufacturing practices and subsequently, the applications for new drugs to be produced from the facility will be put on hold till further notice.

“...this is to inform you that further to our earlier communication on the Goa manufacturing facility inspection conducted from 16-27 September 2019 by the United States Food and Drug Administration (US FDA), the company has received a warning letter from US FDA,” Cipla said in a filing. Following the announcement, Cipla shares fell as much as 6 per cent during early trade on BSE. The scrip recovered, but closed at `422 a share, 0.68 per cent lower than its previous close.

The Mumbai-based firm also said it remains committed to maintain highest standards of compliance and will work closely with FDA to comprehensively address all the observations. It may be noted that over the past few years, the FDA has intensified vigil on Indian drug-makers, who supply more than a third of the generic medicines to the US. Just last year, more than 20 companies were issued warning letters, which cumulatively impact the number of new drug filings from domestic drug-makers.

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