The Medicines and Healthcare Products Regulator Agency (UKMHRA) had conducted an inspection at the company’s facility at Taloja earlier this month with respect to marketing authorisation applications made by the company to the EU countries.
“The company has received inspection report from the UKMHRA on March 30 where eight observations have been made by the regulator. The company is in the process of putting together responses to address observations made by the UKMHRA in the report,” Alkem Laboratories said in a regulatory filing.
The company will submit the responses within the timeline stipulated by the UKMHRA, it added. “The company does not anticipate any impact on its existing registered products in the EU market,” it said.