Citicoline Sodium, CDP-Choline, Citicoline Sodium API, Nucleoside API, Xinxiang Pharmaceutical, USP/EP standard, Neuroprotective agent, CAS No. 33818-15-4
Original Manufacturer: Xinxiang Pharmaceutical Co., Ltd. CDE Registration Status: A GMP Status: Compliant (Issued January 2026) Standard: ChP / USP / EP CEP: Not Applicable International DMF Filings: Available in selected markets (e.g., India, Uzbekistan) Annual Capacity: Please contact us for ...
- Original Manufacturer: Xinxiang Pharmaceutical Co., Ltd.
- CDE Registration Status: A
- GMP Status: Compliant (Issued January 2026)
- Standard: ChP / USP / EP
- CEP: Not Applicable
- International DMF Filings: Available in selected markets (e.g., India, Uzbekistan)
- Annual Capacity: Please contact us for details
Disclaimer: All detailed product information shall be subject to the issued final COA. CDE registration status and GMP compliance are specific to the Chinese regulatory framework. For international filings, please contact us directly with your target market and required documentation.
Acarbose, Acarbose API, Glucobay, Alpha-Glucosidase Inhibitor, CSPC Shengxue, CEP 2011-054, US DMF 35603, CAS No. 56180-94-0
Original Manufacturer: CSPC Shengxue Glucose Co., Ltd. (CSPC Pharmaceutical Group) CEP: Available — R1-CEP 2011-054 US DMF: Available — DMF 35603 EU GMP Certificate: Issued by Germany (March 2024) FDA Inspection Status: NAI (2024) Standard: USP / EP / ChP / JP Annual Capacity: Please contact us for ...
Sevoflurane API, Inhalation Agent, Volatile Liquid, Shandong New Time, Lunan Pharmaceutical, CEP 2012-234, US DMF 22740, USP/EP standard, CAS No. 28523-86-6
Original Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. (Lunan Pharmaceutical Group)CDA No.: H20080680 (API)CEP: Available — CEP 2012-234 (Rev 01, valid)US DMF: Available — DMF 22740 (Type II, Status A)FDA Regulatory Status: Referenced in an approved ANDA for Sevoflurane Inhalation ...
Allopurinol, Zyloprim, USP/EP/BP grade, Huangshi Pharma, Xanthine oxidase inhibitor, Gout treatment API, CAS No. 315-30-0
Original Manufacturer: Huangshi Pharma Co., Ltd. (Huangshi Fam Pharmaceutical)DMF: Available / Not Available CEP: Under Preparation WC (Written Confirmation): N/AStandard: USP / EP / BPAnnual Capacity: 500 MT Disclaimer: All detailed product information shall be subject to the issued final COA. ...
L-Glutathione Reduced, GSH, Reduced Glutathione, Glutathione API, Shandong Jincheng, US DMF 37051, CEP 2024-255, CAS No. 70-18-8
Original Manufacturer: Shandong Jincheng Bio-Pharmaceutical Co., Ltd.US DMF: Available CEP: Available FDA Registration: Active GMP Status: US FDA inspected, Nov 2024 (VAI)Standard: USP / EP / JP All detailed product information shall be subject to the issued final COA. DMF Letters of Authorization ...
