Granules India Ltd. on Thursday announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its facility located in Hyderabad, Telangana.
The pharma company said that the US drug regulator issued an EIR for its Gagillapur facility in Hyderabad. This facility is used for manufacturing finished dosages and Pharmaceutical Formulation Intermediates (PFIs).
In January this year, USFDA conducted an inspection at the Gagillapur facility of Granules India as part of a pre-approval inspection (PAI) and issued three observations.
Granules India has informed the bourses that it responded to the USFDA’s observations on the aforementioned inspection conducted in January 2023 within the stipulated period.
On June 30, 2023, Granules India warned of a significant loss of revenue and profitability due to a cyber-security attack that the pharmaceutical company faced on May 25, 2023. The company had revealed that a ransomware group had claimed responsibility for the incident.
Due to significant changes in its IT systems, the IT security incident caused a major disruption in its business operations.
For the March quarter, Granules India reported a consolidated net profit of Rs 119.6 crore, rising by 7.76 percent on a year-on-year basis from Rs 111 crore in the same quarter last year.
Its net sales increased by 16.07 percent to Rs 1,195.5 crore, compared to Rs 1,029.97 crore in the corresponding quarter of last year.
Shares of Granules India ended 1.94 percent lower at Rs 302.70 on Thursday.
