NCPC’s Azithromycin for Injection Passed Efficacy Consistency Evaluation

In November 2023, Azithromycin for Injection(0.5g) manufactured by NCPC received Drug Supplementary Application Approval Notice from NMPA, marking its authorization in quality and efficacy consistency evaluation for generic drugs.

Azithromycin for Injection is indicated for community-acquired pneumonia and pelvic inflammatory infections caused by sensitive organisms. More stringent control items and limits have been established in its quality standard with reference to Chinese Pharmacopeia (ChP) and European Pharmacopeia(EP) combined with process and actual production conditions.  

After two year’s careful research comparing with referenc drug, NCPC applies higher quality control based on the previous standard, which further guarantees safety and effectiveness of the product. Azithromycin for Injection is manufactured from freeze-dried powder, the production is delivered by two freeze-drying systems from two world top manufacturers: German GEA and Italy IMA. In addition, liquid preparing system from Morimatsu Japan, automatic lamp inspection system from BREVETTI Italy, automatic packaging system from IWK Germany, fully closed automatic material loading and unloading system from GEA Germany and other advanced equipment have hugely mitigated sterility risk posed by manual operation. .

The two freeze-drying systems are suitable for large-scale production. NCPC strives to provide high-quality and affordable medicine to the public under highly productive, energy efficient and continuously improving management.