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.

78
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.

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news