Tuesday, 26 April 2011
Galenica acknowleges that its US partner Luitpold Pharmaceuticals, Inc. has announced that they have voluntarily suspended, for a temporary period, the manufacturing and distribution of products from its Shirley, New York, facility. This voluntary suspension follows a recent FDA inspection. Venofer® was not the subject of the inspection report or subsequent discussion with the FDA.
_Luitpold is a licensee of Venofer® and manufactures Venofer® for the US and Canadian markets at its Shirley facility. None of the FDA’s observations identified specific concerns with the production of Venofer®. The production of Venofer® was temporarily suspended as part of the overall production suspension at the site. There are no concerns related to the quality of Venofer® on the North American market.
_Luitpold is developing a plan to resume manufacturing and distribution as soon as possible. Luitpold is also in communication with the FDA Drug Shortage Staff to address any potential shortages of drug products critical to patient health. Stocks in trade of Venofer® are currently at a two-month level for the North American market.
_Based on the more than 20 years of partnership and experience of Luitpold’s quality and safety record, Galenica has full confidence that Luitpold will effectively resolve the issues highlighted by the FDA. Galenica will post a notice as soon as distribution and production of Venofer® resumes.
Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).
Thursday, 15 December 2011
Monday, 12 December 2011
Tuesday, 15 November 2011
Monday, 14 November 2011
Head of Corporate Communications