Quality, Safety and Environment
Quality Assurance
- Quality has always been a key focus for Minakem and strong resources are dedicated to keep improving our Quality Assurance system.
- Minakem's plant runs under current Good Manufacturing Practices (cGMP) and it has been FDA approved since 2002. The latest FDA inspection took place in 2006.
- Our manufacturing facilities are also frequently audited by our clients for Starting Materials, Key Intermediates and API's. On average, 15 to 20 client quality audits are performed every year.
- Minakem supplies its clients with the full range of documentation required for filing a new drug applications (NDA), in addition to providing the following regulatory support :
- writing DMF's
- establishing Compliance with European Pharmacopea Certificates (CEP)
- submitting ELINCS notification files to the respective authorities
- performing stability studies following the ICH guidelines
Custom manufacturing
MINAKEM core business activities are :
- Synthesis of Starting Materials for the fine chemical industry in dedicated facilities with cost-effective processes, within or out of cGMP guidelines when not required.
- Custom Manufacturing of Key Intermediates for the pharmaceutical industry with finishing stages in qualified cGMP plants
- API's manufacturing under cGMP guidelines
Catalogue products
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Contact us
For further information :
MINAKEM SAS
145 Chemin des Lilas
59310 Beuvry la Foret
FRANCE
Phone: +33 3 20 64 68 30
Fax : +33 3 20 64 68 31
E-mail: contact@minakem.com
MINAKEM SAS
145 Chemin des Lilas
59310 Beuvry la Foret
FRANCE
Phone: +33 3 20 64 68 30
Fax : +33 3 20 64 68 31
E-mail: contact@minakem.com
MINAKEM : 145 Chemin des Lilas - 59310 - Beuvry la Foret - FRANCE
Phone : +33 (0)3 20 64 68 30 - Fax : +33 (0)3 20 64 68 31 - E-mail :
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