Sun Pharma announces US FDA Approval for Generic Amphotericin B Liposome Injection

Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries and/or associate companies), today announced 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.

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 US$ 136 million in USA.

Shares of Sun Pharmaceutical Industries Limited was last trading in BSE at Rs. 775.55 as compared to the previous close of Rs. 755.95. The total number of shares traded during the day was 359587 in over 6149 trades.

The stock hit an intraday high of Rs. 778.75 and intraday low of 745.45. The net turnover during the day was Rs. 272721437.00.

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Source : Equity Bulls

Keywords

SunPharmaceuticalIndustries INE044A01036 USFDA ANDA Approval AmphotericinBLiposome