The pharmaceutical company said that its Gagillapur facility located at Hyderabad has completed the United States Food and Drug Administration's (USFDA) pre-approval inspection (PAI) with 3 observations.
The pre-approval inspection was conducted from 9 January 2023 to 13 January 2023. The drug maker said that it will respond to these observations within the stipulated time period.
Gagillapur facility manufactures finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs).
Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present across the manufacturing of entire pharmaceutical value chain - from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs).
The company's consolidated net profit rose 79.8% to Rs 145.10 crore on 29.5% rise in net sales to Rs 1150.73 crore in Q2 FY23 over Q2 FY22.
Shares of Granules India were down 0.82% to Rs 315.40 on the BSE.
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