Indoco Remedies has received final approval for its Abbreviated New Drug Application (ANDA) for Rasagiline 0.5 mg and 1 mg tablets from the United States Food & Drug Administration (USFDA). Rasagiline is used for treatment of Parkinson's disease. The market size of this product in the US as per IMS 2018 data is $105 million.
This is the first ANDA approval for the company after receipt of warning letter in March 2017 for Goa plant II and III. The Company has 32 ANDAs pending for approval for different dosage forms from this site.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.