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Business EconomyPosted at: Nov 8 2024 6:12PM


Granules India receives EIR from US FDA for Unit V Facility

Hyderabad, Nov 8 (UNI) Granules India Limited, a leading pharmaceutical manufacturing company, on Friday announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Unit V facility located at Jawaharlal Nehru Pharma City (JNPC), in Anakapalli district of Andhra Pradesh.
The inspection was conducted by the US FDA from April 8 to April 12, 2024, the Pharma company said in a release here.
The US FDA inspection classified the facility as "No Action Indicated" (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required.
This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas.
During the inspection, the FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, underscoring Granules India’s commitment to stringent quality control, regulatory compliance, and operational excellence.
"The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations," said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director.
Granules India’s Unit V facility plays a pivotal role in the company’s mission to deliver high-quality and accessible pharmaceuticals globally by prioritizing regulatory compliance, operational excellence, and value delivery to stakeholders.
The company remains dedicated to producing top-quality pharmaceutical products that meet global health standards.
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