Wyeth boosts manufacturing in US plant as Puerto Rico site struggles
closure while it is dealing with ongoing manufacturing deficiencies
in its Puerto Rico facility.
The company said it has increased the manufacturing and packaging of its anti-depressant drug Effexor at its Rouses Point, New York, plant to meet production demand.
"This is of a very short-term nature although no end date has been fixed," Wyeth spokesperson Wendy Kouba told In-PharmaTechnologist.com.
Effexor is the only product seeing augmented production in the Rouses Point facility while Wyeth is working to address manufacturing issues at its other plant in Guayama in Puerto Rico.
Wyeth's troubles started in May with a warning letter from the US Food and Drug Administration (FDA) about its Puerto Rico plant, in which the regulator expressed concerns about the good manufacturing practice (GMP) violations that were discovered between November and December 2005 during the agency's inspection of the company's manufacturing facility in Guayama.
These violations resulted in a strongly-worded warning letter from the FDA to which Wyeth responded and has been working since to ensure compliance and avoid site closure or other severe action.
"We are working closely with the FDA to address manufacturing issues at the Guayama facility and we are making progress. However, more work lies ahead," said Kouba
She wouldn't confirm if the company would have resolved its manufacturing problems by the end of the year as it was previously expected.
The GMP violations identified by the FDA affected several drugs including Effexor and the company's Triphasil oral contraceptive.
Although the New Jersey-based company said at the time that the production at Guayama of most of its drugs, including Effexor, had not been affected, it now seems that the company decided to make a u-turn.
Furthermore, Wyeth's decision to step up production in the Rouses Point plant comes as a surprise since the drugmaker announced last year its plan to close down the facility by 2008.
However, "our long-term strategy remains the same and we are aggressively marketing the facility for potential buyers", said Kouba.
