Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global Pte., Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, 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, e.g., emphysema and chronic bronchitis. Theophylline Extended-Release Tablets, 300 mg and 450 mg have a combined market size of around $11.5 million, with the 300 mg dosage contributing around $10.8 million as per IQVIA. The Theophylline Extended-Release Tablets, 300 mg and 450 mg will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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