Granules India trades down despite zero observation from US FDA

Granules India: The US Food and Drug Administration (US FDA) has inspected the company’s Unit V facility at Visakhapatnam during April 8 and April 12 and concluded the said audit with zero 483s. This audit was a pre-approval inspection (PAI) and cGMP audit for active pharmaceutical ingredients (APIs) and formulations (FDs), oncology and non-oncology. This facility manufactures APIs and formulations of oncology and non-oncology products.

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26 Aug, 2025 12:21

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Shares of Granules India traded down 1.5 percent in early trade on April 15 even after the US FDA issued no section 483 observation on completion of an audit on the Visakhapatnam facility.

At 9:47am, Granules India was quoting Rs 415.95, down Rs 6.00, or 1.42 percent, on the BSE.

The company’s Unit V facility at Anakapally in Visakhapatnam, Andhra Pradesh, underwent an inspection by the US drug regulator from April 8 to 12. This audit was a pre-approval inspection (PAI) and cGMP audit for active pharmaceutical ingredients (APIs) and formulations (FDs); oncology and non-oncology, which resulted in Zero 483's.

This facility manufactures APIs and formulations of oncology and non-oncology products.

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The share touched a 52-week high of Rs 480.50 and a 52-week low of Rs 272.00 on 26 February, 2024 and 25 May, 2023, respectively. Currently, the stock is trading 13.43 percent below its 52-week high and 52.92 percent above its 52-week low.