PolyPeptide regulatory milestones

Regulatory Milestones

The PolyPeptide Group manufactures a third of all approved commercial peptide API’s in the world.  Our regulatory history is exemplary in the industry. 

With the exception of our generics facility  in India, each PolyPeptide site has undergone at least one Pre-Approval Inspection (PAI) conducted by the US FDA.

The following Regulatory  Agencies have inspected the PolyPeptide Group’s facilities,  totalling to more than 30 inspections globally:

  • US Food and Drug Administration (FDA)
  • California Food and Drug Branch
  • ANSM  (Agence nationale de sécurité du médicament et des produits de santé [
  • Korean FDA
  • Swedish Medical Products Agency
  • Danish Medicines Agency
  • Japan Ministry of Health and Welfare

 

Malmö Hillerød Strasbourg Torrance San Diego
Site Insp. Pre-App Site Insp. Pre-App Site Insp. Pre-App Site Insp. Pre-App Site Insp. Pre-App
US FDA
09 / 2013

10 / 1997
05 / 2001
06 / 2004
09 / 2005
09 / 2008
10 / 2009

09 / 2013

09 / 2013 09 / 2008  

08 / 2009

04 / 2014

12 / 2004

01 / 2008 

01 / 2010
04 / 2013

03 / 1999

07 / 2001

09 / 2001

11 / 2002

03 / 2009

02 / 2012

1992

1995

1998

2002

2004

2005

2010

2011

2012

07 / 2009
Japan Ministry of Health and Welfare
               

2007

2012

 
Korean FDA
06 / 2012   06 / 2012         10 / 2007   2005
Swedish Med. Ag Danish Med. Ag. AFFSAPS Californian FDA Californian FDA
  Every 3 years   Every 3 years

2006

2010

2014

    Use FDA inspection   1990
1992
2002
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