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Jubilant Life Sciences receives USFDA's approval for Zolmitriptan ODT Tablets

18 Sep 2015 Evaluate

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg, the generic version of Zomig-ZMT (of Astra Zeneca), which is used for acute treatment of migraine headaches in adults.

As on June 30, 2015, the company had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe.

Jubilant Life Sciences is an integrated global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Specialty Pharmaceuticals and Life Science Ingredients.

 

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