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:
establishing European Conformity Certificates (ECC's)
submitting ELINCS notification files to the respective authorities
performing stability studies following the ICH guidelines