The Hindu Business Line : Morepen gets USFDA nod for Himachal facility

MOREPEN Labs Ltd has received a fresh US Food and Drug Administrator approval for its active pharmaceutical ingredient (API) manufacturing facilities at Masulkhana, Himachal Pradesh.

The facility is currently manufacturing anti-histamine drug Loratadine for which it had received an approval by the FDA in March 1999. According to a company statement, the inspection for the current approval was the first after the drug went off patent in December 2002 and commencement of supplies.

"The fresh USFDA approval comes at a time when the company is consolidating its operations and further planning to boost its turnaround efforts. The debt restructuring talks with the bankers are also at an advanced stage of consideration," said Mr Sushil Suri, Chairman and Managing Director, Morepen Laboratories. The company has regular supply contracts with companies such as Novartis and Merck.

To leverage on the USFDA approved infrastructure at Masulkhana, Morepen has added two more products to the facilities. These two molecules, Citalopram and Sertraline, are anti-depressant drugs that command a combined market size of $4.25 billion (Rs 19,125 crore). The Drug Master Files (DMFs) for them are expected to be filed in the next six months.

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