Granules India Limited has announced that its Unit V facility in Anakapally, Visakhapatnam, Andhra Pradesh, India, has successfully completed an inspection by the US Food and Drug Administration (FDA) with flying colors. The inspection, conducted between April 8th and 12th, 2024, resulted in zero 483 observations, signaling a flawless performance by the facility.

Unit V specializes in the manufacturing of Active Pharmaceutical Ingredients (APIs) and formulations for both oncology and non-oncology products. The audit, which served as a Pre-Approval Inspection (PAI) and cGMP audit, underscores the facility's commitment to maintaining high-quality standards in its production processes.

Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India, expressed his pride in the achievement, emphasizing the company's unwavering focus on excellence in quality control. He remarked that receiving zero observations from the US FDA reaffirms Granules India's dedication to meeting and even surpassing global standards in pharmaceutical manufacturing. Dr. Chigurupati also reiterated the company's commitment to continuing its efforts in manufacturing products that contribute to enhancing healthcare.

The successful completion of the FDA inspection without any observations underscores Granules India's reputation for adherence to stringent quality protocols, further solidifying its position as a trusted player in the pharmaceutical industry.