Natco Pharma Ltd.

BSE: 524816 | NSE: NATCOPHARM
Small Cap | Pharmaceuticals & Drugs
908.10
-8.15 (-0.89%)
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Natco Pharma’s marketing partner gets approval for Carfilzomib Vials

Date: 14-06-2021

Natco Pharma’s marketing partner -- Breckenridge Pharmaceutical Inc (BPI) has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS), from the U.S. Food and Drug Administration (USFDA). The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. Based on the ANDA filing date NATCO believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.