SPL Set ID: e896cbfe-4745-4088-82a3-8dc10b75c41f

Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is a modified oral formulation of cyclosporine that forms an aqueous dispersion in an aqueous environment. Cyclosporine, the active principle in Gengraf ® Capsules, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Aphanocladium album . Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl). Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains cyclosporine, 25 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.). Each 100 mg capsule contains cyclosporine, 100 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.). The chemical structure for cyclosporine USP is Inactive Ingredients FD&C Blue No. 2, gelatin NF, polyethylene glycol USP, polyoxyl 35 castor oil NF, polysorbate 80 NF, propylene glycol USP, sorbitan monooleate NF, titanium dioxide. The chemical structure for cyclosporine USP is: