Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ wholly-owned subsidiaries has received final approval from USFDA 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.

Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by USFDA 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 Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.