Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login
Purity min 99.5% by HPLC; complies with BP/EP/USP monograph; particle size D90 < 250 micron; moisture < 0.5%; heavy metals < 10 ppm; EU GMP certified facility; EDQM CEP under filing; annual stability data available; ICH Q7 compliant manufacturing
EDQM CEP expected Q3 2026. Facility passed BfArM EU GMP inspection May 2024 with zero critical findings. 10 years manufacturing history. Current annual capacity 2,000 MT. Willing to supply reference samples on signed NDA. Analytical data package including impurity profile and degradation studies available.