Where we are

MANUFACTURER OF API comprising
Low Molecular Weight Heparins, polysaccharides derivatives, peptides and phospholipids.
Full scale production plant for Peptides operative since mid-2012.

APIS CERTIFICATIONS

  • Filed accreditation JP PMDA
  • Authorized by the Italian Ministry of Health
  • cGMP compliance
  • US-FDA inspected since 1985

PEPTIDES MANUFACTURER

The Cinisello site is dedicated to the development and medium scale GMP production of Peptides.

www.chemipeptides.com

APIs CERTIFICATIONS

Chemi Cinisello is regularly inspected by Italian national agency (AIFA) and by FDA; several peptides and processes have been accredited in both Europe (EMA) and Japan (PMDA).

CERTIFICATIONS

  • GMP compliance
  • Authorized by the Brazilian Ministry of Health (ANVISA)
  • Last US-FDA inspection: march 2014
  • Mexican Health Authority inspected (Cofepris): May 2011
  • French Health Authority inspected (Afssaps): Sept 2011
  • Filed accreditation JP PMDA

CERTIFICATIONS

  • Pharmaceutical plant is regularly inspected by the Italian Health Ministry (according to the EU cGMP’s). Last AIFA inspection took place in May 2015
  • Since 2004 the plant has been inspected and approved by FDA for aseptically filled products. Last FDA inspection took place in March 2015
  • Prefilled syringes plant has the JP PMDA accreditation
  • Pharmaceutical plant has been inspected by Turkish Health Authority in February 2015 and has been registered in the United Arabian Emirates (UAE) Ministry of Health in June 2015