Last Updated on December 21, 2024 by The Health Master
USFDA
The US Food and Drug Administration (USFDA) has issued a No Action Indicated (NAI) Establishment Inspection Report (EIR) to Granules India Limited for the Unit V facility located in Jawaharlal Nehru Pharma City (JNPC), Andhra Pradesh.
Zero 483 Observations
The USFDA conducted a rigorous inspection of the facility from April 8 to April 12, 2024.
The inspection, which included a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, resulted in zero Form 483 observations.
This outcome is a testament to the facility’s adherence to stringent quality standards and current Good Manufacturing Practices (cGMP).
A Strong Foundation for Future Growth
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India, expressed satisfaction with the successful inspection.
He emphasized the company’s unwavering commitment to maintaining the highest quality standards in all manufacturing operations.
The NAI classification reinforces Granules India’s position as a reliable supplier of high-quality Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas.
Approvals
Incorporated in 1991, Granules India is a vertically integrated pharmaceutical company headquartered in Hyderabad, India.
The company boasts a comprehensive manufacturing capability, encompassing APIs, Pharmaceutical Formulation Intermediates (PFIs), and FDs.
Granules India’s products are distributed to over 300 customers in regulated and semi-regulated markets across 80+ countries.
With a strong regulatory footprint, including approvals from the USFDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, KFDA, DEA, MCC, and HALAL, Granules India is well-positioned to continue its growth trajectory and contribute to global healthcare.
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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