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09 Sep 2024
Admin
News Article

Strides Receives US FDA Approval For Theophylline ER Tablets, 300 mg and 450 mg

Overview

Strides Pharma Science’s step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received the United States Food & Drug Administration (FDA) approval for the generic version of theophylline extended-release tablets, 300 mg and 450 mg.

Bioequivalence With THEO-DUR

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

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 Bengaluru.

Indications

Theophylline extended-release tablets (300 mg and 450 mg) are used to manage respiratory onditions 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.

About Strides

Strides, mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor- funded markets.
The Company’s global manufacturing sites are located in India: Chennai, Puducherry, and two locations in Bengaluru, Italy at Milan, Kenya at Nairobi, and the United States in New York.

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