The inspection, which was conducted from August 26 to September 6, 2024, focused on the current Good Manufacturing Practices (cGMP) and Pre-Approval Inspection (PAI) processes. Granules India has committed to address these observations and will submit its response to the US FDA within the required timeframe.
“The recent inspection covered both Current Good Manufacturing Practices (cGMP) and Pre-Approval Inspection (PAI) processes. Granules India is committed to addressing the observations promptly and will submit its response to the US FDA within the stipulated time frame,” Granules India said in a regulatory filing.
Read also: Granules India shares fall after surprise inspection at key facility: Exclusive
The Gagillapur facility plays a key role in the manufacturing of finished dosage (FD) and pharmaceutical formulation intermediates (PFI), supporting the company’s global operations.
The drugmaker witnessed a significant expansion in its net profit and margins during the June 2024 quarter, while its operational performance also turned out to be stronger. For the April-June period, the company’s net profit rose to ₹135 crore. In the same quarter last year, Granules India posted a net profit of ₹48 crore.
Its operating revenue grew 19.7% year-on-year to Rs 1,179.8 crore, while earnings before interest, tax, depreciation and amortisation (EBITDA) at Rs 259.2 crore in Q1FY25 registered a year-on-year increase of nearly 90%. EBITDA margin rose to 22% in the reported quarter, expanding sharply by 800 basis points (bps) from 14% in the year-ago period.
Read also: Granules India Q4 results: Paracetamol maker posts 8% rise in profit; net debt falls
Shares of Granules India Ltd closed at ₹687.50, down ₹10.30 or 1.48% on the BSE.
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