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Sun Pharma Announces US FDA Approval for Generic Mesalamine Extended Release Capsules

Thursday, May 12, 2022

Sun Pharmaceutical Industries Limited, today announced that it has received final approval from US FDA 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, 500mg as a reference product.

As per March 2022 IQVIA Health data, Pentasa® Extended Release Capsules, 500mg had annualized sales of approximately US$ 213 million in USA.

® - All brand names and trademarks are the property of respective owners

Disclaimer:
Statements in this Document describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the interpretations of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments or circumstances after the date hereof.

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050):
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 cont inents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter@SunPharma_Live.

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