USFDA approval granted for Theophylline Extended-Release Tablets

This USFDA approval marks a major step forward for Strides Pharma in expanding its presence in the US market.

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USFDA Approval
USFDA Approval

Last Updated on September 30, 2024 by The Health Master

USFDA approval

Strides Pharma Science, a leading global pharmaceutical company, has achieved a significant milestone with the USFDA approval of its generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, by the United States Food and Drug Administration (USFDA).

This USFDA approval marks a major step forward for Strides Pharma in expanding its presence in the US market.

A Breakthrough for Respiratory Health

Theophylline Extended-Release Tablets are a vital medication used in symptoms and reversible airflow obstruction associated with chronic asthma, emphysema, and chronic bronchitis.

These conditions can significantly impact a person’s quality of life, and effective treatment options are essential.

Bioequivalence and Therapeutic Equivalence

Strides Pharma’s generic version of Theophylline Extended-Release Tablets has been determined to be bioequivalent and therapeutically equivalent to the brand-name drug, THEO-DUR.

This means that it delivers the same therapeutic effect as the original medication.

A Significant Market Opportunity

The combined market size of Theophylline Extended-Release Tablets, 300 mg and 450 mg, in the United States is estimated to be approximately $11.5 million, with the 300 mg dosage accounting for the majority of the market.

This represents a significant opportunity for Strides Pharma to capture a share of this growing market.

Manufacturing Excellence

Strides Pharma’s Theophylline Extended-Release Tablets will be manufactured at its state-of-the-art facility in KRS Gardens, Bengaluru, India.

This facility is known for its high quality standards and adherence to stringent regulatory requirements.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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