USFDA Concludes Inspection Of Indoco Remedies’ Goa Facility

The US Food and Drug Administration (USFDA) successfully audited Indoco Remedies’ sterile manufacturing facility in Goa (Plant II) during the period from October 7 to 15, 2019.

The Inspection concluded  with 2 observations; neither of which is  related to Data Integrity or the core Quality Management System.The company is expected to  respond to the FDA within the stipulated time while the site continues to maintain its VAI status.

This is the second successful Pre-Approval Inspection (PAI) of this site in less than 6 months, which indicates a steady progress in the review of our pending Abbreviated New Drug Applications (ANDAs). As of now, Indoco has 39 ANDAs pending for approval from this site.

Last week, the company had received the final approval for its ANDA for Rasagiline 0.5 mg and 1 mg tablets from the USFDA. Rasagiline is used for the treatment of Parkinson’s disease.

Indoco Remedies Limited is a fully integrated, research-oriented pharma company with a presence in 55 countries. It has 9 manufacturing facilities, of which 6 are for FDFsand 3 are for APls. The company is also supported by a state-of-art R&D Centre and a CRO facility.

On Wednesday, the stock of Indoco Remedies opened at Rs. 137.00. It quickly surged by 10.5 per cent to Rs. 155.40 in the morning trading session from its previous close of Rs. 140.55. – DSIJ