In a reprieve to Sun Pharmaceuticals, the US Food and Drug Administration (USFDA) has resolved its issues with the company on the manufacturing practices in one of its American production facilities.
In a letter dated September 13, USFDA said it was satisfied with the corrective actions by Sun Pharma after the regulator issued a warning letter for manufacturing practice violations at Sun’s Cranbury facility in New Jersey. The agency had also withheld the approval of new drug applications from the facility on August 25.
The USFDA statement said though Sun seems to have addressed the violation(s) contained in the warning letter, future FDA inspections and regulatory activities will further assess the adequacy and sustainability of the corrections. In a press release today, Sun Pharma said the site now has an acceptable regulatory status.
While the company has resolved the regulatory issues related to its Cranbury facility, USFDA is yet to give a clean chit to the company’s wholly-owned US subsidiary — Caraco. Sun said it continues to work with consultants to resolve the issues raised by USFDA at Caraco’s Detroit plant.
The financial implications of the USFDA warning letter to the Cranbury facility was minimal as it used to manufacture limited products — four or five controlled substance drugs or drugs that come under the narcotics category. Caraco, however, holds a much important position in Sun’s US growth strategy.
Daiichi Sankyo-owned Ranbaxy Laboratories was also banned by FDA three years earlier for violating manufacturing norms at two facilities in India.
Ranbaxy is yet to get clearance from the regulator.