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On October 29th, the State Drug Administration issued "Drug Approval Certificates for October 29th, 2020 to be released", with a total of 14 varieties passing or as if they had passed a consistency evaluation, of which 3 were injected. The supplements were evaluated consistently, namely, the "Garnierk Injection of Acetic Acid", the "Injection Boron Tezome" of Chiru and Howson, and the "Sodium chloride injection of Moxisa Sorghum hydrochloride" in Curran.
recently passed or as if through the consistency evaluation details table according to pharmaceutical data show that Shenzhen Binhai Pharmaceutical injection mero permutation also through the consistency evaluation, so far 7 injections through the supplementary application through the consistency evaluation.
Injection supplement application through the conformity evaluation details table since May this year, injections have basically become the main force of consistent evaluation, every week more than half of enterprises declare different varieties of injection consistency evaluation, in fact, before the National Drug Administration did not carry out injection work, there are enterprises preemptive layout, so now there is news of injection consistency evaluation.
48 injections have passed the consistency evaluation, Hengrui, Qilu most according to the drug intelligence consistency evaluation data show that so far, a total of 48 injections through or as if through the consistency evaluation (the end of the text attached to the evaluation details table).
From the enterprise's point of view, the acceptance number for Sichuan Huiyu Pharmaceuticals and Tiando Pharmaceuticals each have 5 receiving numbers approved, followed by Staili, Chengdu Bett, Hengrui Pharmaceuticals and Qilu Pharmaceuticals each have 4 receiving numbers.
However, Qilu Pharmaceuticals has a maximum of 5 varieties, namely, injected with yew alcohol (albumin binding), injected with Parecheb sodium, injected with bivaldding, Osali platinum injection, injected with boron titzomi, injected with Parexib sodium as the first supplement to apply for evaluation of the variety; Respectively, the injection of yew alcohol (albumin binding type), injection of estramine, hydrochloric acid acetamine injection, Glon bromide injection, and in addition to injection with yew alcohol (albumin binding type), the remaining three varieties are currently no enterprise evaluation;
from the pharmacological type, the evaluated injections, mainly anti-tumor and immunologic regulatory drugs, accounted for 20.43 percent, followed by systemic anti-infective drugs, accounting for 18.28 percent.
188 injections have been declared consistent evaluation, Colum, Qilu leading according to the pharmaceutical intelligence consistency evaluation database shows that, up to now, CDE cumulative acceptance consistency evaluation acceptance number 966, involving 213 enterprises 188 varieties, of which the most competitive is injection With cephalosporine sodium, 55 receiving numbers were accepted by 21 enterprises to declare, followed by ammonia hydrochloride bromoso injections with 35 acceptance numbers, involving 19 enterprises;
data sources: Pharmaceutical intelligence data from the perspective of enterprises, injection consistency evaluation and declaration of enterprises for the largest infusion leading enterprises Colum Pharmaceuticals, there are 58 acceptance number 34 varieties were undertaken, followed by Qilu Pharmaceuticals and China Biopharmaceuticals have 50 acceptance numbers (26 varieties) and 44 acceptance numbers (21 varieties) were accepted.
of which Chinese biopharmaceutical injections are mainly declared by Zhengda Tianqing.