2 Granules units finish USFDA audit

Hyderabad: Pharma player Granules India Limited informed the bourses that two of its manufacturing facilities at Visakhapatnam and Hyderabad have completed US Food & Drug Administration’s (USFDA) inspections with zero 483 observations within a span of two weeks.While the pre-approval inspection and GMP (good manufacturing practices) audit for Granules India’s Unit IV at Visakhapatnam in Andhra Pradesh was conducted from June 26 to 30, 2023, the Jeedimetla facility at Hyderabad in Telangana successfully completed the USFDA surveillance inspection between June 19 to 23, 2023.The Unit IV facility at Visakhapatnam manufactures active pharmaceutical ingredients (API), while the Jeedimetla facility manufactures APIs as well as pharmaceutical formulation intermediates (PFIs).The company said the zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
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