Granules’s Unit V Facility Successfully Completes FDA Inspection

Granules’s unit V facility in Visakhapatnam successfully completes US FDA inspection with zero 483 observations

Overview

Granules India Limited, a vertically integrated fast-growing Indian pharmaceutical company, announced that the company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, India has successfully completed the US Food and Drug Administration (FDA) inspection between 8th and 12th April 2024, resulting in zero 483 observations.

About Approval

This audit was a Pre-Approval Inspection (PAI) and cGMP audit for active pharmaceutical ingredients (APIs) and formulations (FDs) for oncology and non-oncology products.

Words from Granules India

“We are very proud to reiterate that our focus on high-quality standards is comparable to the best global benchmarks as we receive zero observations from US FDA audits. We will continue to move ahead and manufacture products that will enhance health care,” said Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India.

About Granules India

Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.

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