Indoco Remedies gets USFDA approval for its Rasagiline ANDA

Indoco Remedies Limited has received the 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 USD 105 million.

As per the management of the company, this is the first ANDA approval for Indoco 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.

Last month, the company had announced about the successful conclusion of inspection conducted by the UK Health Regulator, MHRA at its sterile manufacturing facility (Plant II) at Verna, Goa.

Indoco Remedies is a research-oriented pharma Company with presence in 55 countries. It has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APls, supported by a state-of-the-art R&D Centre and a CRO facility.

On Monday, the stock of Indoco Remedies opened at Rs 141. During the day, it jumped by 7.1 per cent making intraday high of Rs 150.30 from its previous close of Rs 140.40.