Morepen gets USFDA approval for API manufacturing
By Our Corporate Bureau | 09 Mar 2004
New
Delhi: Morepen Labs Ltd has received a US Food and
Drug Administrator (USFDA) approval for its active pharmaceutical
ingredient (API) at Masulkhana, Himachal Pradesh.
The facility is presently manufacturing anti-histamine drug Loratadine for which it had received an approval by the USFDA 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.
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