Portugal's Hovione is in expansion mode. After saying last month that it would add to its plant in New Jersey, the contract manufacturer now says it has acquired a formulation plant in Portugal.
The company said on Monday that it had acquired a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures and will use it to develop and manufacture both inhaled and oral-dosage forms.
The facility is being designed to handle highly potent APIs as well as moisture-sensitive compounds and will have dedicated rooms so it can produce both kinds of products concurrently. The facility will produce material for clinical trials through commercial batches, it said in a release.
Spokeswoman Isabel Pina said in an email that Hovione picked up the facility from Generis, a Portuguese generic pharmaceutical company. She said the total investment in the building, equipment and refurbishing will run about $10 million. The work should be done and the plant operating by October 2016.
Hovione CEO Guy Villax said in a statement, "I am sure our customers will value the option of not having to ship the material that comes out of our reactors and spray dryers to outside the walls of our site and away from our trusted quality culture."
That quality culture was bruised just a bit last year when the company announced that during a preapproval inspection at the Loures plant the FDA had issued a Form 483 with three observations. The company promised to jump on the problems and to use the insight to improve operations at other facilities.
This is the second expansion project the company has announced in the past three weeks. Late last month, the CMO said that it would add 30,000 square feet to its facility in East Windsor, NJ, for a new commercial spray-dryer unit to complement an existing unit. It was also being designed to handle HPAPIs. The expansion will more than double the facility's drug substance capacity and is expected to add about 60 new jobs to the current workforce. That project is getting underway early next year and is slated to be complete in early 2017. The company also added a spray dryer to the Loures plant earlier this year.
- here's the release