Hyderabad-headquartered Granules India has reported the completion of a pre-approval inspection by the United States Food and Drug Administration (USFDA) at its Gagillapur facility in Telangana.
The company said that the USFDA issued three observations after its pre-approval inspection, which was conducted from January 9 to January 13, 2023.
The Gagillapur facility manufactures finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs).
Granules will build a Greenfield facility for large-scale manufacturing of key starting materials (KSMs), Intermediates, APIs, and fermentation-based products. The facility spread across 100 acres will be commissioned in a phase-wise manner. The estimated cost of the project will be approximately Rs 2,000 crore over five years.
The company has scheduled the earnings conference call for the December quarter on January 24.
Granules India is a leading pharmaceutical company with a presence in over 80 countries across the world, including the United States and the United Kingdom. The company has six manufacturing facilities in India and one in the US.
The Granules India stock ended 1.08 percent lower at Rs 314.90 on Monday.
(Edited by : Rukmani Krishna)
