Last Updated on September 30, 2024 by The Health Master
USFDA inspection
Bengaluru, India – Strides Alathur Private Limited, a fully-owned subsidiary of Strides Pharma Science Limited, has successfully cleared a rigorous US Food and Drug Administration inspection (USFDA inspection).
The formulation facility located in Alathur, Chennai, underwent a comprehensive Good Manufacturing Practices (GMP) assessment from April 1 to 5, 2024.
A Positive Outcome for Strides
The USFDA inspection concluded with a favorable outcome for Strides Alathur, as the USFDA issued a Voluntary Action Indicated (VAI) rating.
This classification signifies that while minor issues or deviations were identified, they were not severe enough to warrant regulatory action.
The company is now free to continue operations without any administrative or regulatory hurdles.
Focus on US and Regulated Markets
The Alathur facility holds a pivotal role in Strides’ global operations, catering to the highly regulated US market and other international regions.
Specializing in the production of tablets and capsules, the facility is instrumental in supporting the company’s current and future product pipeline for the US.
About Strides
Strides Pharma Science Limited, headquartered in Bengaluru, is a prominent player in the global pharmaceutical industry.
The company is listed on both the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE).
With a strong focus on regulated markets, Strides has adopted an “in Africa for Africa” strategy and serves donor-funded markets through its institutional business.
The company’s manufacturing footprint extends across India, Italy, Kenya, and the United States, with a commitment to producing complex and challenging pharmaceutical products.
Strides’ products are distributed in over 100 countries worldwide.
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.
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