The US FDA had inspected Indoco's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa), from August 31 to September 4, 2016 and issued six observations in Form 483.
Indoco Remedies on Friday said it got a warning letter from US FDA for two of its facilities in Goa, as the drug regulator wasn't fully convinced with the drug maker's response for its earlier observations.
The US FDA had inspected Indoco's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016 and issued six observations in Form 483.
The Plant II manufactures ophthalmic and injectables, while Plant III makes tablets.
The observations were related to unexplained discrepancy in batch failures and not adhering to certain procedures related to quality control, prevention of microbial contamination, equipment and its maintenance.
The company said none of the observations were related to breaches of data integrity or data falsification.
"Based on the review of compliance response, (US) FDA accepted our response to 4 observations. However, (US) FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter from USFDA dated 27th March 2017, today," the company said in a statement.
"We as a company are fully committed in resolving the issue and will respond at the earliest," Indoco added.
The company didn't specify the impact of warning letter on sales but said the company can continue to supply products from the above mentioned facility to meet its "obligations to customers and the patients in the United States of America."
The inspection was related to a ophthalmic product called Latanoprost solution which the company supplies to one of its client who was seeking US FDA approval to market the product in US.
Latanoprost is one of the key products for the company.
Indoco has four USFDA approved facilities in India with two formulation or finished dosage plants in Goa and two active pharmaceutical ingredient plants at Patalganga and Rabale in Maharashtra.
The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement the same quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.
The USFDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice (GMP) standards laid down by it.
The agency is particularly stringent when it comes to facilities related to sterile and injectable products that require higher degree of compliance due to danger of contamination.
Indoco had sales of 973.2 crore in FY16, of which domestic formulations constituted 54.4 percent, while the export formulations contributed 39.6 percent, the rest came from active pharmaceutical ingredient and contract research segments.Indoco's announcement came after market hours. Shares of Indoco dropped 1.21 percent to close at Rs.249.95 on BSE, the benchmark Sensex declined 0.09 percent to end at 29,620.50 points.The Great Diwali Discount!
Unlock 75% more savings this festive season. Get Moneycontrol Pro for a year for Rs 289 only.
Coupon code: DIWALI. Offer valid till 10th November, 2019 .