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About Medichem S.A.
Founded in 1972,
Medichem is a Spanish, privately owned company based in Barcelona, engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical industry.
Medichem is one of the world's leading companies in generic APIs and Custom Manufacturing for the life-science industry.
Medichem’s policy is based on timely delivery of high-quality APIs, full technical, regulatory and legal support and direct contact with clients.
For more information on Medichem log on to: http://www.medichem.es/ |
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About the GMP Audit
Medichem was the first API manufacturer to participate in the PharmAssess programme. The GMP audit took place at the Medichem factory located at Celrà, Girona on 24- 25 July 2006.
The re-audit of Medichem was performed on the 30th June and 1st July 2008. The conclusion of this audit was that Medichem continues to be a company that operates to high standards, with facilities, systems and capabilities to manufacture Active Pharmaceutical Ingredients to the Good Manufacturing Practice standards.
The Audit Report includes photographs and is 38 pages long, excluding appendices. Including appendices, and the original 2006 Audit Report, the report is 111 pages long.
The Audit Report provides information on the general facilities and focused on 4 different products sold in the US, Europe and Japan; Chlorhexidine Digluconate, Clozapine, Mirtazapine and Venlafaxine Hydrochloride. Medichem produce many more API products and the findings of the audit could equally apply to these.
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How to Purchase an Audit
There are just two steps to purchasing a conducted PharmAssess Audit Report:
- A Quotation will be sent to you, followed by a Service Agreement, on request, for the purchase of an Audit Report.
- Once we receive approval of the Quotation we will dispatch the Audit Report, accompanied by an Invoice.
Please note that if there are other audits that you are interested in, which are not noted in our GMP Audit Section of this website, please contact us to discuss your audit requirements, which we can arrange on your behalf.
Contact Us
If you require further information about the PharmAssess service offered by Rephine, or you would like to purchase an Audit Report today please contact Sonja Earl in our Commercial Department by:
Email: Use our contact form to email Sonja.
Telephone: + 44 (0) 1227 713 965
Fax: + 44 (0) 1227 713 450
