Patheon wins EMEA approval for Puerto Rico plant
pharmafile | August 13, 2009 | News story | Manufacturing and Production | Patheon
Canadian contract manufacturer Patheon has been cleared to import solid-dose products from its plant in Manati, Puerto Rico, into Europe following a successful regulatory inspection.
The move marks a further advance for Patheon's Puerto Rican operations, which after being acquired in 2004 proved to be drain on the company's resources and pegged back its profitability.
The Puerto Rican operations finally returned to profit in the fourth quarter of 2008, helped by the sale of a loss-making facility at Carolina and the downsizing of another unit at Caguas.
The Manati facility, which specialises in high-volume manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles, won a green light from the European Medicines Agency (EMEA) following a successful inspection by the Medical Products Agency of Sweden.
"The approval of our Manati facility allows us to ship solid dosage product into Europe from Puerto Rico, which provides additional benefit and flexibility for our clients," commented Terry Novak, president of Patheon North America.
The 38,000-square-metre site has three separate manufacturing areas with environmental controls and a ventilation system facilitate explosion-proof manufacturing, including solvent coating of tablets, and was recently upgraded to handle high-potency active pharmaceutical ingredients (HPAPIs).
The facility also has a low-humidity manufacturing suite for moisture-sensitive tablet formats and can also handle the manufacture of controlled release drug products, including those based on pelletisation, matrix and coating technologies.
Takeover saga goes on
Meanwhile, Patheon continues to fend off a hostile takeover bid from private equity firm JLL, which has been steadily amassing a stake in the CMO and is now claiming to hold $73.5 million (57%) of Patheon's restricted voting shares.
JLL has just extended the deadline for its offer, despite continued opposition from Patheon's management, which has dismissed it as inadequate. At the end of July Patheon won a court case brought by JLL that was aimed at ousting some of its directors, and said the verdict had rendered any continued effort by JLL to take over the firm as "irrelevant".
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