Zydus receives final approval for Sirolimus Tablets

09 Jan 2014 Evaluate

Zydus Cadila has received the final approval from the United States Food and Drugs Administration (USFDA) to market Sirolimus Tablets 0.5 mg with 180 days of marketing exclusivity. As per IMS data in 2013, the sales of Sirolimus 0.5 mg was estimated at $11.7 million and the total market for Sirolimus was approximately $203.8 million. The group also received approval for Duloxetine delayed release capsules in different strengths of 20 mg, 30 mg and 60 mg.

The sales for Duloxetine were estimated at $5.5 billion in 2013. While Sirolimus tablets are immunosuppressant drugs used to prevent rejection in organ transplantation, Duloxetine delayed release capsules fall in the anti-depressants segment. The group now has 86 approvals and has so far filed 216 ANDAs since the commencement of filing process in FY 2003-04.

Cadila Healthcare, 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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