TITLE

EURAND'S SUPPLIER SUBMITS RESPONSE TO FDA ON EUR-1008

PUB. DATE
February 2009
SOURCE
Worldwide Biotech;Feb2009, Vol. 21 Issue 2, p8
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
The article reports on an announcement made by specialty pharmaceutical company Eurand NV that its raw material supplier has filed its response to questions relating to the Drug Master File (DMF) raised by the U.S. Food and Drug Administration (FDA) for EUR-1008, an innovative pancreatic enzyme replacement product (PEP). The supplier's response was preceded by Eurand's response submission in August 2008 to questions relating to the manufacture of EUR-1008 in its June 2008 approvable letter.
ACCESSION #
36237379

 

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