Zydus Cadila receives tentative approval from USFDA for Doxepin HcI tablets

27 Feb 2013 Evaluate

Zydus Cadila has received tentative approval from USFDA for Doxepin Hcl tablets in the strengths of 3 mg and 6 mg. The estimated sales in 2012 as per IMS for Doxepin Hcl, which falls in the neuropsychiatry segment was $15.5 million. It is scheduled to be launched in June 2020 upon patent expiry.

The group now has 77 approvals and has so far filed 172 ANDAs since the commencement of the filing process in FY 2003-04.

The flagship company of Zydus Cadila Group, focuses on various areas, such as formulations (human and veterinary), new drug discovery, novel drug delivery, pharmaceutical ingredients, analytical research, phytochemistry, biotechnology, plant tissue culture, etc.

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