US FDA carries on criticizing wayward Sun plant in Halol

By Gareth Macdonald contact

- Last updated on GMT

US FDA carries on criticizing wayward Sun plant in Halol

Related tags: Food and drug administration

The US FDA has warned Sun Pharmaceutical Industries about its facility in Halol, India just months after it withdrew approval for an epilepsy drug made at the site.

Sun announced it received the US Food and Drug Administration (FDA) warning letter on December 19, explaining that it was issued in response to observations made by the agency during an inspection in September 2014.

The Indian drugmaker said it had called in external consultants and is working to address the problems identified during the 2014 inspection.

However, according to a Reuters​ report, the FDA is not happy with remediation efforts that have been undertaken so far.

The Agency has not yet published the warning letter.

In September​ the FDA’s concerns about Halol prompted it to withdraw its approval​ of Elepsia XR ((Levetiracetam), which is an extended-release migraine drug produced at the site that Sun had intended to launch in the US next year according to a July business update​.

Halol history

The US Food and Drug Administration (FDA) has a complex relationship with Sun’s Halol site.

In 2012, the agency temporarily allowed Sun to produce a generic version of the cancer drug Doxil (doxorubicin hydrochloride) at the site for the US market as a result of shortages​ caused by the problems at J&J's supplier Ben Venue.

Since then the FDA’s view of the Halol plant has been less positive.

Last September agency inspectors found incomplete records during a surprise visit to the site, prompting Sun​ to begin implementing corrective measures.

The Elepsia XR approval was viewed as an indication these efforts were working although – as analysts pointed out during an earnings call last month​ – when the US FDA rejected Sun’s Xelpros (Latanoprost) in August it cited ongoing problems​ at the facility. 

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