NCPC’s Piperacillin Sodium and Tazobactam Sodium for Injection, Amoxicillin Sodium and Clavulanate Potassium for Injection Take the Lead in Passing the Efficacy Consistency Evaluation in China

March 4th., 2021, NCPC received Drug Supplementary Application Approval Notice for Piperacillin Sodium and Tazobactam Sodium for Injection (strength: 1.125g, 2.25g, 4.5g) issued by National Medical Products Administration, stating the drug product has passed Efficacy Consistency Evaluation for Generic Drugs (hereafter abbreviated as “Consistency Evaluation”), NCPC has thus become the first manufacturer passing the consistency evaluation of this drug product in China. This also marks the first parental product of NCPC passing consistency evaluation.

Piperacillin Sodium and Tazobactam Sodium for Injection is a compound powder for injection composed by piperacillin sodium and tazobactam sodium. Being one of the first-line anti-infective drugs with a significant clinical efficacy, it is widely indicated for severe infections. This drug has been included in National Essential Drug List of 2018, categorized as Class B Drug in National Healthcare Insurance Catalogue of 2020. More than 20 impurities were studied during the evaluation, involving a very tough pharmaceutical research project, however, our research team was determined to overcome all the difficulties, they discussed the test results relentlessly and kept improving study protocol, their efforts ended up with an optimal formulation, better technology process, less impurities and better purity. The drafted analytical procedure for related substances has laid the foundation of quality standard for a series of piperacillin sodium products. MENET data shows that piperacillin sodium and tazobactam sodium has a very important place both in clinical domain and in medicine market. The sales volume of piperacillin sodium and tazobactam sodium in 2019 in terminal public medical institutes was over 8 billion RMB, increased up to 2.4% comparing with the year before. The sales growth slowed down in the first half of 2020, but piperacillin sodium and tazobactam sodium still took the leading place in all systemic anti-bacterial generic drugs with a market share of 5.76%.

Piperacillin Sodium and Tazobactam Sodium for Injection is an important strategic product of NCPC, its consistency evaluation success will definitely bring more social benefits via its reliable quality and good clinical efficacy.

On August 23rd., 2021, Amoxicillin Sodium and Clavulanate Potassium for Injection (strength: 0.3g, 0.6g, 1.2g) also passed Efficacy Consistency Evaluation for Generic Drugs (hereafter abbreviated as “Consistency Evaluation”), NCPC is the first manufacturer passing the consistency evaluation of this drug product in China. 

Amoxicillin Sodium and Clavulanate Potassium for Injection is a compound powder for injection composed by amoxicillin sodium and clavulanate potassium (5:1).  It is the first β-Lactamase inhibitor compound preparation in the world. As a anti-inflammatory drug for infections caused by sensitive organisms, ithas been widely applied in anti-infective treatment after being launched into market. Amoxicillin Sodium and Clavulanate Potassium for Injection has a significant place in antibacterial treatment because of its high safety and efficacy, it is categorized as Class B Drug in National Healthcare Insurance Catalogue of 2020.