IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

FDA revokes warning letter issued to facility acquired by Siegfried

9:01 AM MST | February 16, 2015 | Deepti Ramesh

Siegfried (Zofingen, Switzerland), a producer of active pharmaceutical ingredients (APIs), pharma intermediates, and finished drugs, says that the US FDA, last week, revoked a warning letter issued against its sterile filling production facility at Hameln, Germany. The sterile filling facility became a part of Siegfried when the company acquired Hameln Pharma in November 2014. The FDA has now declared production at Hameln to be in accordance with all regulatory requirements, Siegfried says. The revocation of the warning letter permits an American customer to...

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