Description
Magnesium Sulfate, Heptahydrate, USP, EP from Macco Organiques is manufactured for use as an Active Pharmaceutical Ingredient (API) and supported by current FDA Drug Master File (DMF # 31105).
For use in parenteral applications, Magnesium Sulphate Heptahydrate, USP, EP is packed in a GMP Q7 certified facility equipped with clean rooms that meet ISO 8 standards.
· Pharmaceutical industry standard CFR 210/211 cGMP packaging facilities
· Complete in-house testing capability
· Supply chain transparency
· Change control and batch traceability
· Comprehensive regulatory and scientific documentation
· ISO Class 8 certified clean packaging facilities
· ISO 9001:2015 quality standard
· FDA-registered manufacturing facility
· FDA-audited facility
· U.S. FDA DMF
· U.S. NDC # 67706-0012, # 67706-0013
· cGMP to ICH Q7a for API manufacturing
· Temperature-controlled warehouse
· Technical support
Macco has a passion for quality and for prevention of contamination throughout all production stages, which is why they were hand-selected by Spectrum Chemical as our manufacturing partner for biopharma and parenteral drug products.
The company offers physically modified mineral salts and customized packaging including blending, grinding/crushing, milling and repackaging (upon request). All products are packed in a GMP Q7 certified facility equipped with clean rooms that meet ISO 8 standards.