Successful Inspection of Helsinn Birex Pharmaceuticals Dublin, Ireland by the US Food and Drug Administration
22/07/2008 12:59
PR Newswire
DUBLIN, Ireland, July 22 /PRNewswire/ -- Helsinn is pleased to announce that Helsinn Birex Pharmaceuticals, its
drug facility in Dublin, Ireland, has undergone a successful inspection by
the US Food and Drug Administration (FDA) without any Form 483 observations.
The FDA visit, which lasted 5 days, was a pre-approval inspection related to
Helsinn's supplemental New Drug Application (sNDA) for the softgel form of
Palonosetron which is currently under review by the FDA, and also a general
Good Manufacturing Practice (GMP) inspection relating to all products
supplied to the US market. "We are very pleased with this outcome which
confirms the ongoing high standards of Good Manufacturing Practice (cGMP)
compliance at the company, its management and staff as well as the investment
in high quality facilities and systems by Helsinn," said Dr. Riccardo
Braglia, CEO.
Helsinn Birex Pharmaceuticals is the Drug Product manufacturing and
supply services subsidiary of the Helsinn Group producing finished
pharmaceuticals for Helsinn's partners globally and managing the outsourcing
of specialist dosage forms for existing and new products. The Company,
originally established in 1982, employs more than 140 people and has been in
operation in its current facility since 1997.The main products supplied from
Helsinn Birex Pharmaceuticals are Nimesulide (non steroidal
anti-inflammatory), Palonosetron (anti-emetic) and Klean-Prep(R) (a gastro
intestinal lavage).In 2007 it completed the construction of a 2500 sq m
extension of the existing premises to accommodate new additional temperature-
controlled warehouse space, employee facilities, new office and plant
services space as well as additional production capacity. To date Helsinn has
invested over EUR10 million in facilities and equipment for the production of
the various Palonosetron product lines.
About Helsinn Healthcare SA
Helsinn Healthcare SA is a privately owned pharmaceutical group with
headquarters in Switzerland and is the worldwide licensor of palonosetron.
Helsinn's core business is the licensing of pharmaceuticals in therapeutic
niche areas. The company's business strategy is to in-license early stage new
chemical entities and complete their development from the performance of
pre-clinical/clinical studies and CMC development to the attainment of market
approvals in strategic markets (US and Europe). Helsinn's products are
eventually out-licensed to its marketing partners for distribution. The
active pharmaceutical ingredients and the finished dosage forms are
manufactured at Helsinn's cGMP facilities and supplied worldwide to its
customers. For more information about Helsinn, please visit the company's Web
site at http://www.helsinn.com.
Contact:
Helsinn Birex Pharmaceuticals Ltd.
Padraig Somers - General Manager, Irish Plants
Tel.: +353-1-822-54-04
E-Mail: info-hhc@helsinn.com
Contact: Helsinn Birex Pharmaceuticals Ltd. Padraig Somers - General Manager, Irish Plants Tel.: +353-1-822-54-04, E-Mail: info-hhc@helsinn.com
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