Industry

USFDA approval granted for Generic Pirfenidone Capsules

The USFDA approval granted by the USFDA is in relation to the abbreviated new drug application for Lupin's Pirfenidone capsules.

The Health Master

September 8, 2023

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Last Updated on October 11, 2024 by The Health Master

USFDA approval

In a significant development, Lupin Ltd., a prominent player in the pharmaceutical industry, has gained USFDA approval from the US Food and Drug Administration (USFDA) to introduce its generic Pirfenidone capsules.

These capsules are designed to address the medical needs of individuals battling idiopathic pulmonary fibrosis, a debilitating lung disease.

This regulatory milestone marks a crucial step forward for Lupin as it endeavors to provide effective treatment options for patients.

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USFDA Approval for Generic Pirfenidone Capsules:

Lupin has successfully obtained USFDA approval from the USFDA to launch its generic Pirfenidone capsules.

These capsules are specifically designed to treat idiopathic pulmonary fibrosis, a complex lung condition.

The regulatory green light signifies the official endorsement of the capsule’s safety and efficacy, making it a viable treatment option for patients in need.

Key Details of the USFDA Approval:

The USFDA approval granted by the USFDA is in relation to the abbreviated new drug application for Lupin’s Pirfenidone capsules.

These capsules are formulated with a strength of 267 mg.

The regulatory filing made by Lupin outlines the details of this pivotal development, positioning the company as a frontrunner in providing advanced pharmaceutical solutions.

Generic Equivalent and Manufacturing:

Lupin’s Pirfenidone capsules serve as the generic equivalent of Esbriet Capsules, specifically the 267 mg variant produced by Hoffmann La Roche Inc.

This equivalence underscores Lupin’s commitment to offering high-quality alternatives that maintain the same standards of effectiveness.

The production of this pharmaceutical breakthrough will take place at Lupin’s state-of-the-art Pithampur facility, situated in India.

This facility is renowned for adhering to stringent manufacturing standards and quality controls.

Insights into the USFDA Drug Approval Process:

1. Regulatory Affairs Consulting:

Essential for navigating the complex landscape of USFDA approvals.
Ensures adherence to stringent regulatory guidelines.

2. USFDA Drug Approval Process:

A meticulous process involving rigorous evaluation of safety and efficacy.
Demands comprehensive documentation and compliance with USFDA standards.

3. Generic Drug Approval Pathway:

An economical alternative to brand-name drugs, requiring a robust Abbreviated New Drug Application (ANDA).
Necessitates a thorough demonstration of bioequivalence.

4. USFDA Expedited Programs:

Designed to accelerate the approval process for drugs addressing unmet medical needs.
Includes Fast Track Designation, Breakthrough Therapy Designation, Priority Review Process, and Accelerated Approval Process.

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