Indoco receives EIR from US FDA for oral dosage facility at Goa plant-I
Our Bureau, Mumbai
Thursday, January 18, 2024, 16:30 Hrs [IST]
Indoco Remedies Limited has received the Establishment Inspection Report (EIR) from the US FDA for the Pre-Approval Inspection (PAI) conducted for
the oral dosage form at the manufacturing facility located at Goa Plant-I, L-14 Verna Industrial Area Verna, Goa, 403722, India, in October 2023.
The company had addressed the observations comprehensively and within the stipulated time. The receipt of the Establishment Inspection Report (EIR)
indicates a successful closure of the inspection.
The PAI was conducted for two drug product applications (ANDAs) filed from this facility, for which approvals are expected soon.
Commenting on this development, Aditi Panandikar, managing director, Indoco Remedies said, “We stay committed to enabling affordable access to our
high-quality products for patients in the US and around the world. This is a testament to our commitment to global standards of quality and compliance.”
Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. The company’s turnover is US$ 200 million with a human capital of 6,000 employees,
including over 300 skilled scientists and field staff who are the strength of the organization. The company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs,
supported by a state-of-the-art R&D Centre and a CRO facility.
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