The cessation of production at U.S.-based Catalent's ($CTLT) facility in France due to suspected product tampering has forced GlaxoSmithKline ($GSK) to delay the launch of its hair loss drug in Japan as the pharma giant looks for other manufacturing options.
Catalent halted production at its softgel capsule manufacturing facility in Beinheim, France, last month after regulators began investigating several incidents that appeared to indicate someone within the plant was purposely mixing the wrong capsules into batches. Company officials have said they are working closely with French law enforcement and regulators to uncover they mystery.
Meanwhile, GSK said in an email that it has had to put the launch of Zagallo (dutasteride), which is made at the Beinheim plant and approved only in Japan for alopecia, on hold until more information becomes available on patient safety. 'We are working quickly to resume supply from alternative sites and to conclude our investigation," the company said.
Catalent has said that it was "highly unlikely" the capsules were misplaced in batches by unintentional human error or from a failure in the control process. It was more likely, the company said earlier, that the errors were the result of a "deliberate malicious action by one or more individuals."
The GSK launch delay was first reported by in-Pharma Technologist, and represents the second time in as many months that the drugmaker has had a supply issue in Japan. In September, it was reported that the company was having supply issues for the hepatitis B treatment Tenozet in Japan following damage to its Tianjin, China, plant following the devastating August explosions in that city.
- here's the in-PharmaTechnologist story