Glenmark Generics Inc USA, a subsidiary of Glenmark Generics, has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for zolmitriptan orally disintegrating tablets, its generic version of AstraZeneca’s Zomig-ZMT tablets.
The tentative approval is for the 2.5mg and 5mg orally disintegrating tablets of zolmitriptan and constitutes one of the first tentative approvals granted by the FDA for a generic version of the drug.
The 12 month period ending March 2012, zolmitriptan immediate release tablets and orally disintegrating tablets achieved sales of $131 million and $31 million, respectively.
With this, the company's current portfolio consists of 80 generic products authorized for distribution in the US market and 38 ANDA's filed with the USFDA pending approval.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.
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