Strides receive USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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 ~US$ 11.5 mn, with the 300 mg dosage contributing ~US$ 10.8 mn 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.

Theophylline Extended-Release Tablets (300 mg and 450 mg) are used to manage respiratory conditions like chronic asthma, chronic obstructive pulmonary disease (COPD), and bronchospasm. The medication works as a bronchodilator, relaxing the muscles around the bronchial tubes to ease breathing. It is particularly helpful in preventing and treating symptoms such as wheezing, shortness of breath, and chest tightness. The extended-release formulation allows for prolonged drug release, reducing the frequency of dosing and providing consistent relief from symptoms over time.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 1344.00 as compared to the previous close of Rs. 1363.90. The total number of shares traded during the day was 18029 in over 1732 trades.

The stock hit an intraday high of Rs. 1388.90 and intraday low of 1325.40. The net turnover during the day was Rs. 24379544.00.

Source : Equity Bulls

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StridesPharmaScience INE939A01011 StrdesPharmaGlobal Singapore USFDA Approval USFDA