The company said that the observations would not have an impact on supplies and the existing revenue from the facility.
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The USFDA conducted the GMP inspection of the company's Solid Oral Formulation Facility (Plant 1) in Goa from January 16 to January 20, 2023.
The US drug regulator issued Form-483 with nine observations. Form-483 is given to a company when an investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The Mumbai-based company said that the observations will be taken care of within the stipulated time. It, however, mentioned that the observations would not have an impact on supplies and the existing revenue from the facility. Indoco also noted that it is committed to maintaining compliance across facilities with GMP quality standards.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). The company reported a total revenue of Rs 1,539.72 crore for the previous fiscal.
Indoco Remedies in November 2022 told analysts that it was aiming for full-year revenue of Rs 5,000 crore in less than five years.
Shares of Indoco Remedies ended 3.31 percent higher at Rs 404.45 on Monday.