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On September 18, the NMPA official website released the latest batch of drug approval information.
Haisco's cefotiam hydrochloride for injection passed the consistency evaluation and became the first company to pass the product review
.
Cefotiam Hydrochloride for Injection is the TOP16 product of terminal cephalosporin injections in public medical institutions in China
Figure 1: The latest approved products
Source: NMPA official website
As a second-generation cephalosporin antibiotic, cefotiam hydrochloride has a broad and balanced antibacterial spectrum, and shows a wide range of antibacterial effects on both Gram-negative and positive bacteria
.
According to data from Minai.
From the point of view of the supplementary application for consistency evaluation, six domestic pharmaceutical companies have previously applied.
The first was submitted by Shanghai Pharmaceuticals Xinya Pharmaceutical in February 2020 and is currently under review and approval; Liaoning Haisco Pharmaceutical in 2020 Submitted in May, and now it has successfully overtaken and won the first review; in addition, the acceptance numbers of Harbin Pharmaceutical Group Pharmaceutical General Factory, Chongqing Shenghuaxi Pharmaceutical, Zhejiang Yongning Pharmaceutical and Shandong Luoxin Pharmaceutical Group are also being reviewed and approved.
.
Table 1: Haisco's previous review/deemed review products
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
According to data from Mi Nei.
com, as of now, Haisco and its subsidiaries have reviewed/deemedly reviewed 19 products (including the approved products this time), of which 10 are injections
.
Perindopril tert-butylamine tablets, emtricitabine tenofovir tablets and pramipexole hydrochloride sustained-release tablets won the fourth batch of national procurement, esomeprazole sodium for injection, palonosetron hydrochloride injection and Fatty milk amino acid (17) glucose (11%) injection won the fifth batch of national procurement
Source: NMPA official website, Mi Nei.
The review data statistics are as of September 22, if there are any errors or omissions, please correct me
