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

Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 012 India. Reaching People. Touching Lives FOR IMMEDIATE RELEASE Sun Pharma Announces US FDA Approval for Generic Mesalamine Extended Release Capsules Mumbai, India, May 12, 2022: 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 it has received fi nal approval from US FD A 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 IQVI A 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 ob jectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “f orward 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 mu ltiple 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. Contacts I n v e s t o r s M e d i a Nimish Desai Gaurav Chugh Tel + 91 22 4324 4324, Ext 2778 Tel + 91 22 4324 4324, Ext 5373 Tel Direct + 91 22 43242778 Tel Direct + 91 22 43245373 Mobile + 91 98203 30182 Mobile + 91 98104 71414 E mail [email protected] E mail [email protected]

The release as fetched from its publisher. sunpharma.com ↗