Hubei Gedian Humanwell Norethisterone Norethindrone API Tetracyclic Compound CP EP USP JP Grade

Original Manufacturer: Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Product Name: Norethisterone (Norethindrone)
Standard: CP / EP / USP / JP
CEP: Not Available for Norethisterone 
US DMF: Please contact us for details 
Chinese CDE Registration: Please contact us for details 
EU GMP Status: Company holds EU GMP certification
FDA Inspection Status: OAI (November 2025) 
Annual Capacity: Please contact us for details

Disclaimer: All detailed product information shall be subject to the issued final COA. Norethisterone (CAS 68-22-4) and Norethindrone Acetate (CAS 51-98-9) are distinct substances; regulatory documentation must be confirmed against the specific substance being sourced. US DMF and CEP status for Norethisterone should be verified with our team before relying on any regulatory filing pathway. The manufacturing site's FDA inspection status (OAI, November 2025) is disclosed for buyer awareness.