GMP on the agenda
manufacturing license renewed after a six-week suspension and GSK
unveils a US FDA probe.
AustraIian Pharmaceutical Industries has been given the go-ahead to restart production of therapeutic goods at its Kingsgrove facility in New South Wales, which was shut down voluntarily in early September.
The company requested the six-week suspension in order to put right various non-compliance issues raised by the country's Therapeutic Goods Administration, which monitors adherence to Good Manufacturing Practice (GMP) standards.
API's compliance problems came to light after Pan Pharmaceuticals, Australia's largest manufacturer of over-the-counter medicines, was forced to withdraw hundreds of products for failing to meet GMP standards. A TGA audit earlier this month said that Pan had also put its house in order and was in the frame to activate its manufacturing license.
As of yesterday, the Kingsgrove facility was re-instated bringing an end to a sales halt that the company estimates has cost it A$4 million (€2.4m) in lost revenues. Putting the plant back into shape has also cost it A$1.3 million in additional operating and capital costs.
API said it will progressively recommence manufacturing its products in line with all GMP and TGA requirements.
FDA eyes GSK Puerto Rico plant
Meanwhile, pharmaceutical drug major GlaxoSmithKline has said that a plant it operates in Puerto Rico is under investigation by the US Food and Drug Administration (FDA) over GMP compliance.
The company said in its third quarter results statement, released yesterday, that the FDA has not informed the group of the specific nature of its investigation, although it added that, "records provided to the FDA focus on manufacturing at the site in 2001 and 2002".
The site is engaged in tabletting and packaging for a range of GSK products, primarily for the US market. They include the antidepressant Paxil and Paxil CR (both paroxetine), Coreg (carvedilol) for heart failure and the diabetes treatments Avandia (rosiglitazone) and Avandamet (rosiglitazone and metformin). GSK said it had received no indication that ongoing supply from the site will be affected.
Sites in Puerto Rico were at the heart of the most high-profile case on GMP non-compliance in recent years, which culminated in the issuance of a $500 million (€423m) fine for Schering-Plough.
