Updated on 31 August 2012
Good-to-go: Caraco gets green signal from the US FDA to produce Carvedilol and Paramomycin
Mumbai: The US FDA determined that Sun Pharmaceutical subsidiary, Caraco, is in compliance with relevant paragraphs of the consent decree. The FDA reached its decision folllowing subsequent inspections earlier this year and corrective action by the firm on 483's. Also known as inspectional observations, 483 is a form used by the FDA to document and communicate concerns discovered during its inspections. The FDA notified that Caraco may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan in the US.
During their inspection, the FDA reviewed the certification reports for production of Carvedilol as well as Paramomycin, and subsequently reviewed corrective actions on 483's. Currently, Caraco may resume products of only these two products.
Manufacturing of other products from these sites, including those pending approval with the FDA, will be subject to similar rigorous approval procedure. As a result of this, the increase in production at these sites and resultant revenue contribution is expected to be gradual. With reference to other requirements of the same consent decree, Caraco is required to work with an external auditor, conducting regular inspections for an extended period.