The sterile filling production facility in Hameln acquired by Siegfried in November 2014 as per public knowledge had previously been issued a warning letter by the FDA. End of last week the FDA revoked the warning letter and declared Hameln’s production to be in accordance with all regulatory requirements.
In 2012, the FDA issued a warning letter to Hameln Pharma. Siegfried provided support to the company in compliance matters prior to the acquisition. Now, following revocation of the warning letter, the path has been cleared for the Hameln Pharma facility to be immediately and fully integrated into the Siegfried Group’s worldwide compliance system. The warning letter revocation also permits an American customer to import its product to the USA. The German regulatory authorities have recently confirmed renewal of Hameln’s GMP certificate required in regular intervals.
Siegfried CEO Rudolf Hanko: “This is an announcement which our American customers, es-pecially, have been waiting for. Revocation of the warning letter is the result of joint efforts. It represents a significant step in Hameln’s ongoing integration process into the Siegfried Group.
For further information:
Peter Gehler, Chief Communications Officer
peter.gehler@siegfried.ch
Phone: +41 (0)62 746 11 48
Mobile: +41 (0)79 416 41 16
Siegfried Holding AG
Untere Brühlstrasse 4
CH-4800 Zofingen
Phone: +41 (0)62 746 11 11
Fax: +41 (0)62 746 11 03 www.siegfried.ch
About Siegfried
The Siegfried Group is active worldwide in the field of Life Sciences with production facilities located in Switzer-land, Malta and the USA. At the end of 2013, Siegfried reported annual sales of CHF 375 million and employs at the time being approximately 1500 employees. Siegfried Holding AG is listed on the Swiss Exchange (SIX: SFZN).
Siegfried is active in both the primary and secondary production of drugs. The company develops and manufac-tures active pharmaceutical ingredients for the research-based pharmaceutical industry as well as the corre-sponding intermediate steps and controlled substances, and provides development and production services for drugs in finished dosage forms including sterile filling.
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