Cinacalcet , Cinacalcet API, Calcium-Sensing Receptor Modulator, Lianyungang Guike, USP standard, CAS No. 364782-34-3
Original Manufacturer: Lianyungang Guike Pharmaceutical Co., Ltd.Chinese Approval No.: Please contact us for detailsUS DMF: Please contact us for details CEP: Not Available EU GMP Status: Non-Compliant (August 2026) Standard: USP Disclaimer: All detailed product information shall be subject to the ...
Original Manufacturer: Lianyungang Guike Pharmaceutical Co., Ltd.
Chinese Approval No.: Please contact us for details
US DMF: Please contact us for details
CEP: Not Available
EU GMP Status: Non-Compliant (August 2026)
Standard: USP
Disclaimer: All detailed product information shall be subject to the issued final COA. The EU GMP non-compliance status referenced above is specific to the Lianyungang Guike manufacturing site and does not represent a regulatory determination regarding product quality for non-EU markets. Buyers are responsible for verifying regulatory eligibility for their target market. Please contact us to discuss market-specific 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 ...
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 ...
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. ...
