Strides Pharma Science receives USFDA approval for Theophylline Extended-Release Tablets, 300mg and 450mg

Strides Pharma Science Ltd's step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300mg and 450mg, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR®, of Schering Corp. Theophylline Extended-Release Tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases. The Theophylline Extended-Release Tablets, 300mg and 450mg, have a combined market size of ~USS 11.5 mn. The products will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India. Strides Pharma Science is a global pharmaceutical company headquartered in Bengaluru, India, and is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR).