For several years, Quality has been a major focus of Minakem both in terms of human resources and investing in new equipment.
Minakem's plant runs under strict cGMP conditions (FDA inspected, cGMP compliant).
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) and DMF registration for generic API's, in addition to providing the following regulatory support:
- writing DMF's
- establishing European Conformity Certificates (ECC's)
- submitting ELINCS notification files to the respective authorities
- performing stability studies following the ICH guidelines
- etc...
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
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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