GSK delays Japanese drug launch after Catalent closes plant to investigate tampering

Catalent's production interruption at a French plant because of suspected product tampering is being felt by clients. GlaxoSmithKline ($GSK) has had to delay the launch of a hair loss drug in Japan while it figures out another location that can produce it.

The U.K. company said in an email that Catalent's Beinheim, France, plant manufactures Zagallo (dutasteride) for alopecia, which is approved only in Japan. "The launch of Zagallo (dutasteride) in Japan is on hold until further information becomes available as patient safety has to be our first priority. We are working quickly to resume supply from alternative sites and to conclude our investigation," the company said.

The launch delay was first reported by in-PharmaTechnologist.

U.S.-based Catalent ($CTLT) halted production at the softgel capsule manufacturing facility in Beinheim last month at the request of regulators after several incidents in which it appeared that someone within the plant purposely mixed the wrong capsules into batches. The company has been working with French law enforcement and regulators to find out what happened.

Catalent said at the time that the capsules were "highly unlikely to have been misplaced through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate malicious action by one or more individuals." Catalent said it was working with its clients that were affected by the interruption.

It is the second time in recent months that GSK has had a supply issue in Japan. In September, the Nikkei Asian Review reported that GSK was having problems supplying the hepatitis B treatment Tenozet in Japan after GSK's plant in Tianjin, China, was damaged in August from a series of explosions at a nearby chemical warehouse that ripped through an industrial area. No GSK employees were injured from the blasts, but the plant had to be closed for repairs.

- here's the in-PharmaTechnologist story

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