The drug major has received final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for generic Mesalamine extended release capsules, 500 mg.
The generic product approval is based on Pentasa extended release capsules, 500 mg as a reference product, Sun Pharmaceutical Industries said in a statement.As per March 2022 IQVIA Health data, Pentasa extended release capsules, 500mg had annualized sales of approximately $213 million in USA.
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
The company's board will consider Q4 results on 30 May 2022. The company's consolidated net profit grew 11.13% to Rs 2,058.80 crore on 11.61% rise in total revenue from operations to Rs 9,863.06 crore in Q3 December 2021 over Q3 December 2020.
Shares of Sun Pharma fell 0.64% to settle at Rs 850.15 on Thursday.
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