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Company

Farmabios manufactures and markets active ingredients for pharmaceutical applications and provides custom synthesis services

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Technologies

A wide range of advanced proprietary technologies in accordance with GMP standards and Pharmacopeas specifications.

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Events

No events

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Inspections

Farmabios policy is to identify, document and handle in effectively way the Company processes critical for Customer satisfaction.

For this reason the Company performs analyses and monitoring of all processes and put all actions into practice which are necessary to obtain the targets and the continuous implementation of Company performances.

The most recent Pre-Approval lnspection (or PAI) was carried out by the FDA in Sept. 2010 and the next one is foreseen within the end of 2013.


2013

  • Italian Health Authority (AIFA) - General GMP inspection

2011

  • Italian Health Authority (AIFA) - Authorization to production for new anticancers plant – general GMP inspection
  • KFDA (Corea) - Pre-approval inspection (clobetasol propionate)

2010

  • US FDA - Pre-approval inspection (8 ANDAs – steroids)

2008

  • Italian Health Authority (AIFA) - Authorization to production – general GMP inspection

2007

  • US FDA - Pre-approval inspection
  • KFDA (Corea) - Pre-approval inspection

2005

  • EDQM + AIFA (Italian Health Authority) - Verifications of conformity to Certificate of suitability for cefuroxime sodium sterile - Authorization to production – general GMP inspection

2004

  • Italian Health Authority (AIFA) - Authorization to production – general GMP inspection
  • US FDA - Pre-approval inspection

2001

  • Italian Health Authority (AIFA) - Authorization to production – general GMP inspection

2000

  • US FDA - Pre-approval inspection

1997

  • US FDA - Pre-approval inspection