For pharmaceutical applications, manufacturing of API's (active pharmaceutical ingredients) and critical intermediates are conducted under current Good Manufacturing Practices (cGMP) in our kilo–lab facility (class 10,000), which has been operational since 1988. Strem can optimize a synthetic route to an API that meets strict purity and process control requirements. We also can develop, validate, and justify process and release test methods, complete and evaluate degradation and stability studies, and develop a complete Chemistry, Manufacturing, and Controls documentation package for submission to the FDA within a drug mater file.
Strem operates under a cGMP compliant quality management system compliant to ICH Q7. We are inspected by several customers each year and by the FDA approximately bi-annually. Our customers include both small and large, domestic and international drug companies. We are currently expanding our internal analytical test facilities. Strem works closely with customers to achieve regulatory approvals and maintain a product in a state of validation throughout its lifecycle.
The Newburyport facility was last inspected by the Food and Drug Administration in 2014.
Below is a list of Strem’s Regulatory Filings:
Cisplatin
Carboplatin
Pamidronic Acid
Fomepizole
Dexmedetomidine Hydrochloride
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