Shortages likely as Sandoz’s Canadian plant woes continue
pharmafile | February 20, 2012 | News story | Manufacturing and Production |Â Â FDA, Novartis, SandozÂ
Ongoing compliance problems at a plant in Canada operated by Novartis’ generics subsidiary Sandoz look set to cause supply disruptions for a number of products.
Sandoz has said it plans to stop production of non-essential medicines made at the Boucherville facility in Quebec and concentrate on essential products to try to ease the situation, caused by suspension of most of the production capacity at the plant.
Towards the end of last year Novartis was sent a warning letter by the FDA, saying that inspections had revealed evidence that three North American facilities were not meeting Good Manufacturing Practice (GMP) standards.
Problems cited in the letter included microbial contamination of purportedly sterile drug products, a lack of written procedures designed to prevent contamination, not investigating batch failures properly and deficiencies in the operations of the quality control unit.
The Boucherville site employs 800 staff and specialises in generic sterile injectable pharmaceuticals, with a portfolio of more than 100 products including narcotics, sedatives, antibiotics and ophthalmic agents.
The other sites pulled up by the FDA were both in the US, at Broomfield, Colorado, and Wilson, North Carolina. Sandoz has said it intends to spend around $170 million refurbishing and upgrading the facilities and maintains it has no intention of closing the Boucherville plant.
Sandoz said in a statement released on Saturday that it will have to manage a temporary but significant reduction in output from the Boucherville facility, but is working to restore full production levels ‘as soon as possible’.
The company has decided to stop production of ointment, ophthalmic and suppository formulations of non-essential drugs and concentrate on critical products such as pain-relief medicines, cancer drugs and anti-infectives.
Phil Taylor
Related Content
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
MedPharm announces US FDA inspection of North Carolina manufacturing facility
MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful …
Sandoz launches two new bone disease biosimilars in Europe
Sandoz has announced the European launch of two new bone disease biosimilars. Wyost (denosumab 120 …
