Caraco, a U. S. subsidiary of Sun Pharmaceutical Industries, has finally received approval from the Food & Drugs Administration (FDA) to recommence production of two products, viz. carvedilol and paramomycin.

Carvedilol, a drug for heart ailments; and antibiotic paramomycin are produced and packaged at the company’s Detroit and Wixom facilities in Michigan.

The regulator seized the Detroit, Wixom and Farmington Hills facilities in June 2009, saying the company failed in meeting its current good manufacturing practice (cGMP) requirements. Caraco was ordered to discontinue distribution of products produced at the three units until they assured adherence with cGMP. The early value of the drugs seized by the regulator was estimated in the range of $15million to 20 million.

Following inspections earlier this year, the regulator determined that Caraco was now in compliance with cGMP requirements.

After gaining approval from the USFDA, Sun Pharmaceutical said, "US Food & Drug Administration (USFDA) has notified that Caraco may resume operations at its manufacturing facility and packaging sites in Detroit and Wixom, Michigan.”

However, the company is yet to gain USFDA’s approval for resuming production of its other products at the three units.

Following the announcement, shares in Sun Pharmaceutical gained 1.69 per cent to close at Rs 681.15 on the Bombay Stock Exchange.