Delving into the Latest Updates on Shenzhen Zhijun Pharmaceutical Trade Co., Ltd. with Synapse

Overview

主要目的：本研究以国药集团致君（深圳）制药有限公司持证的磷酸奥司他韦干混悬剂（规格：6mg/mL）为受试制剂，Roche Registration GmbH 持证的磷酸奥司他韦干混悬剂（商品名：Tamiflu，规格：6mg/mL）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂和参比制剂在健康受试者体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: This study used the oseltamivir phosphate dry suspension (specification: 6 mg/mL) certified by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. as the test preparation and the oseltamivir phosphate dry suspension (trade name: Tamiflu, specification: 6 mg/mL) certified by Roche Registration GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date28 Feb 2023

Sponsor / Collaborator

Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

CTR20222637 / CompletedNot Applicable

头孢地尼颗粒在健康受试者中的随机、开放、单次给药、两制剂、两周期人体生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, two-cycle human bioequivalence study of cefdinir granules in healthy subjects

本试验旨在研究餐后单剂量口服国药集团致君（深圳）制药有限公司研制、生产的头孢地尼颗粒（50 mg/包×1包）的药代动力学特征，并以日本LTL制药株式会社生产的头孢地尼细粒剂（Cefzon®，50 mg/包×1包）作为参比制剂，比较两制剂的药动学参数，评价两制剂的人体生物等效性。

[Translation]

The purpose of this study was to study the pharmacokinetic characteristics of a single oral dose of cefdinir granules (50 mg/packet × 1 pack) developed and produced by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. after meals, and to compare the pharmacokinetic parameters of the two preparations with those of cefdinir fine granules (Cefzon®, 50 mg/packet × 1 pack) produced by LTL Pharmaceutical Co., Ltd. of Japan, and to evaluate the bioequivalence of the two preparations in humans.

Start Date16 Nov 2022

Sponsor / Collaborator

Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

100 Clinical Results associated with Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

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0 Patents (Medical) associated with Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

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16

Literatures (Medical) associated with Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

Zhongguo Yaoye

Study of bacterial endotoxins test in cefuroxime sodium for injection

Author: Tu, Xueqiong

The bacterial endotoxins test was performed in cefuroxime sodium injection according to Chinese Pharmacopoeia of 2000 edition.Cefuroxime sodium injection did not bring interference at the concentration of 6.68 mg/mL and the bacterial endotoxin detection limit was 0.15 EU/mg.These results suggest that the bacterial endotoxins test can be used for endotoxin detection in cefuroxime sodium injection instead of pyrogen test.

Xiandai Shipin Yu Yaopin Zazhi

Study on formulation of cefepime hydrochloride for injection

Author: Xian, Jian-cheng ; Zhou, Xiang ; Wang, Lei ; Chen, Zhen-yang

L-arginine (350, 550, 650, 700, 710, 720, 725, 730, 740, 750, 800, and 900 mg resp.) was added to 1 g cefepime hydrochloride for injection.The pH, color and clarity were examinedThe optimum range of quantity of L-arginine added to 1 g cefepime hydrochloride for injection is 720-730 mg.According to the result, 725 mg/L-arginine was added to 1 g cefepime hydrochloride for injection in manufacture process.

Journal of China Pharmaceutical University

Study on related substances and stability of ceftazidime and its preparation

Author: Ni, Kunyi ; Lou, Qiuxia ; Tu, Jie ; Yan, Zhigang

Ceftazidime is unstable to light and heat.The HPLC method for determining the related substances in ceftazidime was presented.The Spherisorb C₁₈ column (200 mm X 4.6 mm, 5 μm) was used with acetonitrile - 0.04M NH₄HPO₄ (1:9, pH 7.0) as mobile phase; flow rate was 1 mL min^-1, and detection wavelength was 254 nm.Ceftazidime, its degradation product (7-ACA), byproduct, and related substances were detected by the method.The stability of ceftazidime and its preparation was studied.The HPLC method was simple, rapid, accurate, and precise, which was better than that of foreign pharmacopeias.

100 Deals associated with Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

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100 Translational Medicine associated with Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

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Pipeline

Pipeline Snapshot as of 01 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Cefdinir ( PBPs )	Vestibular Diseases More	Pending
Cefozopran Hydrochloride ( PBPs )	Keratitis More	Pending
Guaifenesin/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride ( Opioid receptors x α-adrenergic receptor )	Influenza, Human More	Pending