Granules India subsidiary clears USFDA audit

The drug maker on Wednesday announced that its US-based subsidiary cleared a pre-approval inspection (PAI) audit by the US drug regulator.

Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India, located in Chantilly, Virginia, USA had undergone a PAI audit by the US Food and Drug Administration (USFDA) from 21 June 2021 to 25 June 2021.

The audit is a pre-approval inspection for three of its applications filed from this facility. The USFDA issued two minor observations during the audit.

Priyanka Chigurupati, executive director of Granules Pharmaceuticals said, "The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20 of July 2021. This is the fifth US FDA audit for this facility."

Granules India produces finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs). The company along with its subsidiaries has a global presence which extends to over 250 customers in over 75 countries through its offices in India, US & UK and has seven manufacturing facilities out of which six are located in India and one in the USA.

The company's consolidated net profit jumped 38.2% to Rs 127.57 crore on a 33.2% surge in net sales to Rs 799.31 crore in Q4 FY21 over Q4 FY20.

Shares of Granules India fell 2.57%to Rs 368 on Tuesday.

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