Divi's Labs' Vizag plant banned from shipping to US

By Gareth Macdonald

- Last updated on GMT

Related tags Import alert Andhra pradesh

Divi's Labs plant in Vizag (source Google maps)
Divi's Labs plant in Vizag (source Google maps)
Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the 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.

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