The inspection took place from 11th to 15th December 2023.
The drug maker has announced that it has received a communication from the United States Food and Drug Administration (USFDA) indicating the inspection classification as Voluntary Action Indicated (VAI). The inspection was conducted at companys wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, USA.
The USFDA had issued Form 483 with 5 observations post inspection on 16 December 2023, which has been now classified as VAI.
This classification indicates that the US drug regulator will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.
Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).
The pharma company’s consolidated net profit rose 1.06% to Rs 125.65 crore on 0.82% increase in revenue from operations to Rs 1,155.58 crore in Q3 FY24 over Q3 FY23.
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First Published: Apr 03 2024 | 1:22 PM IST
