Sun Pharma gets US FDA approval for Amphotericin B injection

Sun Pharmaceutical Industries said that one of its wholly-owned subsidiaries has received final approval from US FDA for its abbreviated new drug application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial single-dose vial.

The generic product approval is based on AmBisome Liposome for injection, 50 mg/vial as a reference product.

Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, and cryptococcosis.

Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by US FDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for the product.

As per October 2021 IQVIA Health data, AmBisome Liposome for injection, 50mg/vial had annualized sales of approximately $136 million in USA.

Sun Pharmaceutical Industries is the world's fourth-largest specialty generic pharmaceutical company and India's top pharmaceutical company.

The company's consolidated net profit rose 12.92% to Rs 2047.01 crore on 12.54% increase in total revenue from operations to Rs 9625.93 crore in Q2 September 2021 over Q2 September 2020.

The scrip shed 0.91% to currently trade at Rs 768.50 on the BSE.

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