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The US Food and Drug Administration has granted tentative approval to Natco Pharma's Abbreviated New Drug Application (ANDA) for trabectedin for injection (generic for Yondelis) for the 1mg/vial presentation.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
Natco Pharma is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations ("FDF") and active pharmaceutical ingredients ("APIs"). It markets and distributes products in over 40 countries.
On a consolidated basis, net profit of Natco Pharma rose 327.20% to Rs 320.40 crore on 115.60% increase in net sales to Rs 884.60 crore in Q1 June 2022 over Q1 June 2021.
Shares of Natco Pharma fell 0.57% to Rs 651.30 on Wednesday, 17 August 2022.
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