In September, Indian API and finished formulation maker Indoco Remedies received a Form 483 with six observations following an inspection by the US Food and Drug Administration (FDA) at its Goa II facility.
“We submitted our comments to FDA in November 2016 and were eagerly awaiting for the EIR [Establishment Inspection Report],” MD Sundeep Bambolkar said during a conference call Monday.
“Based on the review of compliance, FDA has accepted our response to five observations. However, the FDA remains concerned with one observation pertaining to a specific product for which Indoco is a contract manufacturer [and] on Friday 31 March we received a warning letter from FDA.”
The observation relates only to latanoprost ophthalmic solution – a generic version of Pfizer’s Xalatan – which Indoco makes for a US partner. The contract generates revenue of around INR250m ($3.8m) for Indoco each year.
According to Bambolkar the FDA has concerns about the potential of leakage of the product during shipping and issues with the level of communication Indoco has with its US partner.
He added despite the warning, the FDA has not issued an import alert and Indoco is free to continue to supply this and other products from the Goa plant.
“As for US FDA recommendations we are in the process of appointing a cGMP consultant and we shall respond to the warning letter within the stipulated time of 15 days. We will continue to supply the existing product from the aforementioned facility to meet our obligations to our customers and the patients in the USA.”
During the call, Indoco did not reveal its US partner but it is fully aware of the problem.