NEWS: Successful FDA Audit of Pen-G K & Amoxicillin Trihydrate facilities
Delft, The Netherlands, 2004
DSM Anti-Infectives is pleased to announce
that the Food & Drug Administration (FDA) successfully audited two
facilities of DSM Anti-Infectives Fersinsa Gist Brocades (FGb) in Ramos
Arizpe, Mexico. Two FDA inspectors visited the Fermentation facility for
Pen-G K in March/April 2004 and the Synthesis facility for Amoxicillin
Trihydrate in April 2004. Both facilities were subjected to a thorough GMP
inspection for a total of eight days. The inspectors stated in the closing
meetings that the facilities would be recommended for approval. This follows
the successful FDA inspections for the Nystatin facility in Capua, Italy in
2003 and the Clavulanic acid facility in Strängnäs, Sweden in 2002. These good
results show that DSM Anti-Infectives is dedicated to comply with the most
stringent requirements of GMP and compliance.
For the near future DSM Anti-Infectives has the ambition to get FDA approval
for the Purimox® (Amoxicillin Trihydrate) facility in Almeria, Spain. DSM
Anti-Infectives has already filed the Drug Master File for Purimox® at the
FDA. Purimox® is the only enzymatically produced Amoxicillin Trihydrate in the
world and therefore has unique product characteristics including an
exceptional purity, improved physical properties, an environmentally friendly
production process and a bigger batch size. Purimox® has contributed to more
efficient formulation processes, resulting in overall cost savings for
formulators and is already becoming a worldwide success.
For any further questions or more information, please contact DSM
Anti-Infectives Head Quarters in Delft, The Netherlands or your local sales
representative of DSM Anti-Infectives.
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