The company is engaged in manufacturing active pharmaceutical ingredients (APIs) and intermediates for generics, custom synthesis of API's and advanced intermediates for discovery compounds for pharma giants.
The United States Food and Drug Administration (USFDA) has issued an import alert for Divi’s Laboratories Visakhapatnam unit-II due to quality and data integrity issues. The company is engaged in manufacturing active pharmaceutical ingredients (APIs) and intermediates for generics, custom synthesis of API’s and advanced intermediates for discovery compounds for pharma giants.
An import alert means that products from the facility, which are meant for imports, can be refused without examination and will not be allowed to be marketed in the US.
“We wish to state that USFDA has issued an Import Alert 66-40 on 20th March 2017 on the products manufactured at the company’s Unit-II at Visakhapatnam, Andhra Pradesh,” the company said in a notice to stock exchange.
“The agency has exempted the following products from the Import Alert: Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC core succinate and 2,4-wing active ester,” the company said.
“Divi’s Laboratories, along with third party consultants, is currently working to address the concerns of the USFDA and is making all efforts to fully meet the compliance requirements,” the company added. The company’s Visakhapatnam unit II contributes about 60% to total sales and 20% to US sales.
The USFDA had inspected unit-II of the Visakhapatnam plant between November 29 and December 6, 2016 and had issued a Form 483 to the unit with five observations relating to deviations from norms.
“The observations that Divi’s got as a Form 483 which now got converted to import alert, are observations which are purely related to quality control and data integrity,” analysts said adding that this is a major set back for the company. Being a contract manufacturer, the regulatory mechanism is bound to tighten up as there would be huge revenue impact from global players, analysts added.