Last Updated on March 22, 2025 by The Health Master
USFDA approval
The United States Food and Drug Administration approval (USFDA approval) has been granted to Lupin Limited for their Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg.
This development paves the way for Lupin to potentially enter the market for a critical treatment option for Lambert-Eaton myasthenic syndrome (LEMS).
Understanding Amifampridine
USFDA approval of Amifampridine Tablets, 10 mg, are designed to be bioequivalent to Catalyst Pharmaceuticals’ Firdapse Tablets, 10 mg.
This means they are expected to deliver the same therapeutic effect.
Indication of the drug:
The drug is used in the treatment of a rare autoimmune disorder “Lambert-Eaton myasthenic syndrome” (LEMS) which affects the communication between muscles and nerves.
LEMS can lead to muscle weakness, fatigue, and other debilitating symptoms.
Manufacturing in Goa
Amifampridine Tablets will be manufactured at Lupin in its Goa facility.
The facility follows the quality control standards to ensure the drug meets all its regulatory requirements of the USFDA.
This commitment to quality is crucial for building trust among patients and healthcare providers.
If looking for information on “generic drug manufacturing India” this is a great example.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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