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Upfront
Glenmark gets tentative approval for Terbinafine
Our News Bureau - Mumbai
Glenmark Pharmaceut-icals received tentative approval from the USFDA for its
ANDA for Terbinafine HCL 250 mg oral tablets. It is the AB-rated generic equivalent
of Novartis' anti-fungal Lamisil tablets with annual sales of over $650 million
in the US.
Glenmark is manufacturing the finished dose formulation at
its USFDA approved manufacturing facility in Goa, India. Glenmark's US subsidiary,
Glenmark Pharmaceuticals USA will start marketing the product in the US upon
patent expiry. With this approval, GPI now has a portfolio of 16 generic products
for the US market and has over 35 ANDAs undergoing USFDA approval process/launch.
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