Natco Pharma gets DCGI nod for production of ‘Black Fungus’ drug

Natco Pharma gets DCGI nod for production of ‘Black Fungus’ drug

Natco Pharma share price jumped over 11% in the morning session on May 24. The stock has been in focus after the Drug Controller General of India (DCGI) approved application of five companies incuding Natco Pharma to begin production of antifungal drug Amphotericin B liposomal injection, which is critical in the treatment of Mucormycosis, also called ‘Black Fungus’.

Natco Pharma initiated phase-III clinical trials of Molnupiravir capsules to evaluate its efficacy in treating patients with mild COVID-19. The Hyderabad-based firm’s first dose under the phase-III trials was given to a patient in the city-based Yashoda Hospitals.
The pharma has received final approval from the US Food and Drug Administration (US FDA) for abbreviated new drug applications (ANDA) for two products, including an anti-cancer drug for which the company and its marketing partner had settled a litigation with Celgene.

Natco’s marketing partner, Breckenridge Pharmaceutical Inc (BPI), has received final approval for its ANDA for Everolimus tablets (generic for Zortress), from the regulator.
BPI plans to launch 0.25mg, 0.5mg and 0.75mg strengths of the product shortly, which are indicated in the prophylaxis of organ rejection in kidney transplantation and liver transplantation. As per industry sales data, Zortress and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.

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