Subsequently, the Goa facility has received a warning letter from the United States Food and Drug Administration (USFDA) on 17 December 2024. The facility was inspected from 16 July to 26 July 2024.
The company stated that it remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis.
“We will work with the USFDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across our facilities. We continue to supply products from the above-mentioned Facility to meet our obligations to our customers and the patients in the United States of America,” stated the firm in a regulatory filing.
Indoco Remedies is engaged in the manufacturing and marketing of Formulations (finished dosage forms) and active pharmaceutical ingredients (APIs).
The pharmaceutical company’s standalone net profit declined 61.40% to Rs 12.79 crore on 15.18% slide in revenue from operations to Rs 394.58 crore in Q2 FY25 over Q2 FY24.