Registered with the U.S. Food and Drug Administration under 21 CFR Part 207. Registration number available on request.
Quality management system aligned to ICH Q10 guidelines, covering process performance, product quality monitoring, and continual improvement.
Facility operates under current Good Manufacturing Practice per 21 CFR Parts 210 and 211. Full validation documentation maintained on-site.
We Serving Over 100+ countries around the world since 2010
Deviation rate held below 0.4% across all commercial batches. Every Country logged, every requirement with documented
SOPs, batch release protocols, deviation logs, and CAPA records are maintained in validated electronic systems. Audit-ready packages issued within five business days of a qualified request.
Manufactured to specification. Documented to audit.