Indoco Remedies has informed that USFDA inspected its solid dosage plant in Goa (Unit I). At the end of the inspection, the plant has received 8 observations (483s). The filling indicates that all the observations are correctable and the company is in the process of preparing its response for the same.
Exports from Goa solid dosage plant constitute less than 10 percent of the Indoco’s total exports and less than 4 percent of the total sales.
This development might have a negative impact on the stock.
Previously, USFDA had inspected Indoco’s two drug manufacturing units (I&II) at Goa plant in 2016 and had issued 6 observations in Form 483. The company was issued a warning letter with respect to Ophthalmic Product leakage. Unit I had received clearance in 2015.
Company has manufacturing facilities located at Goa, Baddi, Waluj, Rabale and Patalganga. – IIFL