INDOCO REMEDIES GOA STERILE PLANTS RECEIVED WARNING LETTER
News: Indoco Remedies sterile Plant II and Plant III facility located in Goa has received a warning letter from the USFDA. This is followed by the OAI classification received earlier for Plant II and Plant III facility in Goa on 11 October 2024.
Views: These plants are under OAI status for more than a year and the impending warning letter is just a culmination of the status. Indoco is shipping majority of the new products from plant I which is currently out of the embargo. US accounts for ~16% of the overall sales. Although the revenue impact may not be significant, the remediation costs are likely to remain at the elevated level. That said, the impact is already in the price.
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