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.
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.
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.
USFDA Approval granted for Isotretinoin Capsules for Acne Treatment
USFDA approval issued for Mycophenolate Mofetil for Oral Suspension
USFDA approval granted for Topiramate ER Capsules
USFDA approval granted for Generic Pirfenidone Tablets
USFDA approval granted for Generic Doxepin Hydrochloride Capsules
Natco Pharma faces Antitrust Lawsuit over generic Cancer Drug
Vitamin B17: Unmasking the Controversial Cancer cure Myth
USFDA issued EIR to Aurobindo Pharma: Telangana
Drug alert: 7 drugs identified as NSQ in Rajasthan
Telangana IPGA Hosts Workshop on Good Teaching Practices
USFDA Approval granted for Isotretinoin Capsules for Acne Treatment
Delhi High Court prioritizes hearing on ban on Cough Syrup
Drug alert: WHO issues urgent Alert over fake liver drug in India and Turkey
Delhi High Court upholds inclusion of Medical Devices as Drugs under…
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: