Caraco Pharmaceutical Laboratories, US-subsidiary of Sun Pharmaceuticals, has received a warning letter from the US FDA withholding approvals of pending new drug applications.
Caraco’s new drug approvals suspended
MUMBAI: Caraco Pharmaceutical Laboratories, US-subsidiary of Sun Pharmaceuticals, has received a warning letter from the US Food and Drug Administration (FDA) withholding approvals of pending new drug applications of products manufactured out of the company’s Detroit facility.
The warning letter was issued on October 31, as a follow-up of the FDA inspection of the facility in May, which identified certain technical inefficiencies.
The letter puts 19 of Caraco’s new drug approvals on hold until the company responds and further action is taken by the US FDA.
A statement issued by Caraco to the American Stock Exchange stated that the observations in the warning letter included the “inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company’s standard operating procedures. The FDA considered some of its observations to be repeat observations.”
The company said it intends to respond to the letter within 15 days and is working cooperatively and expeditiously with the FDA to resolve the matter.
While Caraco’s new drug approvals are withheld, none of its or parent company Sun’s current product sales would be impacted, a Sun spokesperson said. “All the products that are currently marketed would continue to be sold.”
Out of Sun’s 96 drug marketing applications, which are pending before the FDA, only 19 are out of the Detroit facility. The rest are to be sourced from other manufacturing facilities in the US and India and would not be impacted by the FDA’s warning letter.
Sun holds a 76% stake in Caraco.
An analyst with a Mumbai-based brokerage said while the present business of Caraco and Sun are not affected, the entire future pipeline of Caraco is choked until further action from the US FDA, the timeline for which is not known.
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