About Helsinn
Helsinn's ability to supply packed finished product forms an important part of its complete service (product, marketing assistance, scientific development, and regulatory assistance) to its partners.
Since 1997 these products have been manufactured in a modern facility in Damastown, West Dublin, Ireland which covers an area of 6000 sq. meters on a site next to Helsinn Chemicals Ireland Ltd which produces APIs for the group. The facility is currently being increased by another 3000 sq. m which will be available from mid 2007 and will be used to expand both the number of product lines and production vooumes in the future.
The plant operates to current GMPs and meets the expectations of EU and FDA regulators. It offers manufacturing and packaging services as well as managing the supply chain of other finished dosage forms such as sterile liquids through selected third party manufacturers. In particular, it manufactures finished dosage forms of Nimesulide (NSAID) and Klean-Prep® (Colonic cleaning product), gels and carries out labelling and packaging of the antiemetic product Palonosetron. Its products are sold in Europe, North and South America, Africa and Asia.
The use of efficient design and automation ensures consistently high quality products and Helsinn continues to invest to ensure it has the capacity to supply its partners into the future as well as ensuring compliance with evolving GMP standards. In recent years the company has implemented new functions of Regulatory Affairs and Drug Safety in support of EU market requirements.
Internal manufacturing and packaging capacity is offered for third party contract manufacturing for Oral Dosage Form and Gel/Cream formulation in conjunction with API manufacturing or independently.
The broad range of expertise in development, production, testing and all ancilliary aspects of Drug Product supply is available to clients of the Helsinn Chemical Group if required.
- Focus : Manufacturer
- Industry : Pharma
