Delving into the Latest Updates on Fujian Fukang Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Hemic and Lymphatic Diseases

Respiratory Diseases

Digestive System Disorders

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Hemic and Lymphatic Diseases	1
Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

PBPs(Bacterial penicillin-binding protein)	1

选择健康志愿者进行注射用头孢拉宗钠在人体的单次和多次药代动力学试验，通过进行低、中、高剂量单次和中剂量多次药代动力学试验，测定头孢拉宗的经时血药浓度，估算其主要药代动力学参数，了解注射用头孢拉宗钠在健康人体内的吸收、分布、消除规律，为制定后期试验方案提供试验依据，为临床用药的给药剂量提供依据。

[Translation]

Healthy volunteers were selected to conduct single and multiple pharmacokinetic trials of cefuroxime sodium for injection in humans. By conducting low-, medium- and high-dose single and medium-dose multiple pharmacokinetic trials, the time-dependent blood concentration of cefuroxime sodium was determined, its main pharmacokinetic parameters were estimated, and the absorption, distribution and elimination patterns of cefuroxime sodium for injection in healthy humans were understood, providing an experimental basis for formulating subsequent test plans and a basis for clinical drug dosage.

Start Date-

Sponsor / Collaborator

Fujian Fukang Pharmaceutical Co. Ltd.

CTR20232261 / CompletedNot Applicable

吡拉西坦片随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验

[Translation] A formal randomized, open-label, crossover bioequivalence trial of piracetam tablets in Chinese healthy subjects

主要目的：以福建省福抗药业股份有限公司的吡拉西坦片为受试制剂；并以UCB Pharma S.A.的吡拉西坦片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Main objective: To evaluate the relative bioavailability and bioequivalence of piracetam tablets produced by Fujian Fukang Pharmaceutical Co., Ltd. as the test preparation and piracetam tablets produced by UCB Pharma S.A. as the reference preparation in humans.

Start Date31 Jul 2023

Sponsor / Collaborator

Fujian Fukang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Fujian Fukang Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Fujian Fukang Pharmaceutical Co. Ltd.

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4

Literatures (Medical) associated with Fujian Fukang Pharmaceutical Co. Ltd.

Fujian Fenxi Ceshi

Analysis method for gentamicin with HPLC-PED

Author: Qi, Xueqin

There were considerable advantages in testing gentamicin sulfate on composition and impurities with HPLC-pulse electrochem. detector (PED) method.Besides direct injection, high sensitivity and good resolution, derivation reactions would be avoided.Within the testing range in this experiment, a good linearity was shown along with correlation coefficient exceeding 0.99.In addition, relative standard deviations of both repeatability and robustness in composition test were less than 2%, while that in impurities test was less than 10%, and the detection limit of composition C_2a was as low as 0.002 mg/mL.As could be seen from the testing results, for testing gentamicin sulfate on composition and impurities, HPLC-PED anal. method was convenient and accurate.

Fujian Fenxi Ceshi

Identification of related substances in gentamicin sulfate by LC-MS

Author: Lin, Mei

A LC-MS method for identification of the components and related substances in gentamicin sulfate was developed by optimizing preparations of samples, mobile phase and chromatog. columns.Based on MS spectrometric data and references, the structures of the related substances of gentamicin sulfate were elucidated.The unknown related substances detected in the HPLC with integrated pulsed amperometry detector (IPAD) were identified.The results indicated that there were some impurities, such as Garamine, Gentamicin A3, Gentamicin X2, Gentamicin B, Gentamine C2, JI-20 A, VII-3, Gentamine C2 a, Gentamicin B1 and Sisomicin in Gentamicin sulfate product.The scientific information could be used for production process improvement and quality control.

Jingxi Yu Zhuanyong Huaxuepin

An improvement in control process of continuous sterilizing cephalosporin culture medium

Author: Xu, Cai-shun

Controlling the rational and stable speed of feed liquid and steam is the basic principle in the process of continuous sterilization, so it is an absolute necessary to improve the process control system.Through the improvement on control system of current technol., i.e. setting up an automatic pressure control site on the spray cooling unit, thereby the stability of continuous sterilization temperature and hold time in the process pipe was guaranteed.And the probability of bacterial pollution was reduced, and the potency of zymotic fluid was increased.

100 Deals associated with Fujian Fukang Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Fujian Fukang Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

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

Phase 1 Clinical

1

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