USFDA approval granted for Doxazosin Tablets USP

The USFDA approval ensures that the generic version is equivalent to the brand-name drug in terms of quality, safety, and efficacy.

The Health Master

January 13, 2024

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Last Updated on December 22, 2024 by The Health Master

USFDA approval

Unichem Laboratories, a leading pharmaceutical company, recently achieved a significant milestone by receiving USFDA approval from the United States Food and Drug Administration (USFDA) for its Doxazosin Tablets USP, ranging from 1 mg to 8 mg.

This USFDA approval allows Unichem to market a generic version of Cardura (Doxazosin) Tablets, previously marketed by Viatris Specialty, LLC.

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Understanding ANDA Approval and Its Significance

Abbreviated New Drug Application (ANDA) approval is a crucial step in the pharmaceutical industry.

It allows companies to produce generic versions of existing medications once the patent protection for the original drug expires.

The USFDA approval ensures that the generic version is equivalent to the brand-name drug in terms of quality, safety, and efficacy.

Doxazosin Tablets: A Solution for Hypertension

Doxazosin tablets play a vital role in the treatment of hypertension, effectively lowering blood pressure.

The USFDA approval of Unichem’s generic version signifies a new, cost-effective option for patients in need of this medication.

This development aligns with Unichem Laboratories‘ commitment to providing accessible healthcare solutions.

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Unichem Laboratories’ Goa Plant: Ensuring Quality and Compliance

Unichem’s manufacturing facility in Goa adheres to stringent quality assurance and compliance standards.

The company’s commitment to maintaining high production standards contributes to the reliability and safety of its pharmaceutical products.

Significance of Generic Versions in the Pharmaceutical Market

The USFDA approval of generic versions has far-reaching implications.

It not only provides consumers with more affordable alternatives but also introduces healthy competition into the pharmaceutical market.

Unichem’s generic Doxazosin Tablets aim to bring about positive changes in the industry.

Competition in the Pharmaceutical Industry

Viatris Specialty, LLC, the original marketer of Cardura, operates in a competitive landscape.

The USFDA approval of Unichem’s generic version adds a new dynamic to the competition, potentially influencing market trends and pricing strategies in the generic drug sector.

Cardura and Its Impact on Healthcare

Cardura, the brand-name drug, has been instrumental in healthcare, particularly in managing conditions where blood pressure regulation is critical.

The availability of generic Doxazosin Tablets ensures that the impact of this medication extends to a broader patient population.

The Journey of ANDA Approval: Overcoming Challenges

The journey towards ANDA approval is often fraught with challenges.

Unichem Laboratories‘ successful navigation through this process showcases the company’s resilience and dedication to bringing innovative pharmaceutical solutions to the market.

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.