Divi's Labs' Vizag plant banned from shipping to US
The firm announced the import alert in a Bombay Stock Exchange (BSE) on March 21, explaining that the ban applies to its Unit-II at Visakhapatnam - also known as Vizag - in Andhra Pradesh, India.
Divis said: “The Import Alert by US-FDA for the products manufactured at the company's Unit-II at Visakhapatnam was issued under two clauses 66-40 & 99-32 of the FDA regulations.
According to the US Food and Drug Administration (FDA) website Divis was included on import alert 66-40 because an “inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).”
On the webpage covering import alert 99-32 the agency states that firms included on the alert have either refused to “permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel.”
Divis said it has already initiated necessary measures to address the concerns raised by the US-FDA and is making all efforts to fully meet the compliance requirements.
Ten products made at the facility – specifically levetiracetam, gabapentin, lamotrigine, capecitabine, naproxen sodium, raltegravir potassium, atovaquone, chloropurine, BOC core succinate, 2,4-wing active ester – can still be sold to customers in the US.