Last Updated on November 16, 2024 by The Health Master
Form 483
Shilpa Medicare Limited, a prominent name in the pharmaceutical industry, recently underwent an on-site Good Manufacturing Practice (GMP) inspection with the issuance of Form 483 by the U.S. Food and Drug Administration (USFDA) at its Unit VI facility in Dabaspet, Bengaluru.
The inspection, which took place from October 24 to 30, 2024, was aimed at assessing the facility’s adherence to rigorous quality standards.
Minor Observations, No Major Concerns
Upon completion of the inspection, the USFDA issued a Form 483, which outlines observations related to procedural matters.
It’s important to note that these observations are not considered major violations and are typically addressed through corrective action plans.
Shilpa Medicare is committed to promptly responding to the observations within the specified timeframe.
A Strong Foundation in Pharmaceutical Manufacturing
Shilpa Medicare’s Unit VI is a state-of-the-art facility specializing in the production of Oral Mouth Dissolving Films and Transdermal Systems.
The site has already secured approvals from regulatory authorities in the UK (MHRA) and Australia (TGA) and has been cleared by the USFDA to supply nutraceutical Oral Film products to the U.S. and other international markets.
A Comprehensive Pharmaceutical Portfolio
As a leading pharmaceutical group, Shilpa Medicare offers a diverse range of products and services, including:
- Niche APIs: Active Pharmaceutical Ingredients for oncology and non-oncology treatments.
- Peptides and Polymers: Advanced drug delivery systems.
- Differentiated Formulations: Innovative dosage forms like orally dispersible films and transdermal patches.
- Biologicals: A growing portfolio of biologics.
- CDMO Services: Contract Development and Manufacturing Organization services to support global pharmaceutical companies.
With a robust research and development infrastructure and multiple manufacturing facilities, Shilpa Medicare is well-positioned to meet the evolving needs of the pharmaceutical industry.
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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