Nobelpharma Co., Ltd.: sirolimus

Drug, and Cosmetic Act (FDCA) for sirolimus topical gel, 0.2%.

We remind you that if the API assay for a batch of sirolimus falls outside of @e, it fails to meet the drug substance specification and cannot be used in the manufacture of the commercial drug product.

12.An inspection of the TOYO PHARMACEUTICAL CO. LTD. facility (FEI 3016419927) located in Tsurumi-Ku, Osaka, Japan; is required before this application can be approved.

FDA must assess the ability of that facility to conduct the listed manufacturing operations in compliance with CGMP.

You may respond to deficiencies in this Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and any findings are assessed with regard to your application.