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Another Successful Audit for CARBOGEN AMCIS!

French Health Agency Certifies CARBOGEN AMCIS SAS in Riom, France

29 November 2012

BUBENDORF, Switzerland (November 29th, 2012) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its new site in Riom, France dedicated to the sterile manufacture of fill-finished parenteral drugs was successfully certified by the French Health Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé – ANSM).

 

The Riom site features a 400 m2 area dedicated to the GMP  production of sterile injectables in liquid or freeze-dried form for clinical trials. The site supports aseptic filling of highly potents, cytotoxics, proteins, mAbs , peptides, enzyme inhibitors, antibiotics (non-ß-lactam) and vaccine (non-live) in a wide range of fill volumes (vials, syringes, cartridges and infusion bags).

 

“Quality lies at the heart of CARBOGEN AMCIS,” commented Martin Schneider, PhD, Director Quality and ESH CARBOGEN AMCIS “and these positive audits confirm again our constant commitment to operate to the highest standards of GLP and GMP.”

 

The French Agency’s audit adds to the other successful inspections and external qualifications CARBOGEN AMCIS underwent in the past months:

 

1) May 2012: ANSM GMP Inspection at the Riom, France site for the manufacture of the sterile manufacture of fill-finished parenteral drugs;

 

2) March 2012: SwissMedic GMP Inspection at the Aarau, Switzerland site for the commercial manufacture of active ingredients (read full announcement);

 

3) March 2012: SwissMedic GMP Inspection at the Hunzenschwil (Neuland), Switzerland site for the commercial manufacture of active ingredients (read full announcement);

 

4) March 2012: SwissMedic GMP Inspection at the Bubendorf, Switzerland site for the commercial manufacture of active ingredients;

 

5) February 2012: SwissMedic GLP  Inspection at the Aarau, Switzerland site for process R&D activities of early phase drugs;

 

6) September 2011: FDA Inspection and PAI (Pre-Approval Inspection) at the Bubendorf, Switzerland site for commercial products (read full announcement);

 

7) April 2011: External containment validation according to ISPE ’s guideline at the High Potency facility in Ahmedabad, India on the Dishman site (read full announcement).

 

GMP = Good Manufacturing Practices

mAbs = monoclonal Antibodies

GLP = Good Laboratory Practices

ISPE = International Society for Pharmaceutical Engineering

 

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.

 

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

 

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

 

News
11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

14 July 2016
CARBOGEN AMCIS Sites at Aarau and Neuland in Switzerland Successfully Pass FDA Inspection

31 May 2016
CARBOGEN AMCIS Expands Operations in Bubendorf


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