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MA Results Release | Huasen Pharmaceutical—Terazosin Hydrochloride Capsules Approved!
Release time:
2022-03-23 09:21
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Congratulations to Chongqing Huasen Pharmaceutical Co., Ltd. on receiving the "Drug Approval Notice" for its Terazosin Hydrochloride Capsules (2mg) project. This project was fully managed by Eurasia Huizhi (Beijing) Medical Research Co., Ltd., which was responsible for clinical operations and organizational implementation. During the early stages of the COVID-19 pandemic, when clinical trials were temporarily suspended by institutions across China, the team overcame numerous challenges through joint efforts by both parties. With efficient cooperation among all participating parties and the establishment of scientifically rigorous protective measures, the safety of all involved—medical staff, subjects, and project team members—was ensured with zero infections. In just five months, the pre-trial and formal trials that had been filed were successfully completed. The clinical trial was smoothly concluded, and the ANDA application was successfully submitted. In March 2022, the drug passed the NMPA’s evaluation of quality and therapeutic equivalence for generic drugs, marking the successful completion of this clinical trial.
About Huasen Pharmaceutical
Chongqing Huasen Pharmaceutical Co., Ltd. (stock abbreviation: Huasen Pharmaceutical; stock code: 002907) is located in the High-tech Zone of Rongchang District, Chongqing City, and the Liangjiang New Area of Chongqing City. The company is a national key high-tech enterprise integrating pharmaceutical research and development, production, and sales.
About Eurasia Huizhi
Eurasia Huizhi (Beijing) Medical Research Co., Ltd. is a Contract Research Organization (CRO) specializing in providing Phase I to IV clinical studies and related technical services for new drug development. With 16 years of experience in clinical trial research, over 500 service orders, and an operations management team with more than 15 years of expertise, the company boasts highly compatible clinical and regulatory resources. We offer clients both domestically and internationally comprehensive solutions that are timely, cost-controlled, quality-assured, and professionally optimized. Adhering to a customer-first approach, we collaborate with pharmaceutical companies with integrity, mutual benefit, diligence, and professionalism, guided by clinical value and committed to addressing unmet clinical needs, thereby bringing hope of recovery to patients.
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2020-09-25
Eurasia Huizhi boasts more than ten Phase I strategic collaboration centers, providing high-quality, specialized resources for early-phase clinical studies of innovative drugs. For each project, our expert medical team drafts initial clinical study protocols, consults with clinical experts in relevant fields, and develops clinically feasible and regulatory-compliant implementation plans. The company has extensive experience in conducting clinical trials for a variety of new drugs, including chemical drugs, traditional Chinese medicines, and biologics. Our services include: 1) Feasibility Assessment: Clinical trial feasibility evaluation, identification of centers/researchers, and center feasibility assessment & qualification review. 2) Medical and Clinical Strategy & Planning: Clinical trial planning & execution, risk identification & management.
2020-09-25
Opinions of the General Office of the State Council on Conducting Evaluations of the Quality and Efficacy Consistency of Generic Drugs (Guobanfa [2016] No. 8) Generic drugs that were approved for marketing prior to the implementation of the new classification system for chemical drug registration—and which have not been approved in accordance with the principle of consistency in quality and efficacy with the originator drugs—must undergo consistency evaluations. The consistency evaluation of generic drugs refers to the phased and batch-wise assessment of the quality consistency of generic drugs already approved for marketing, based on the principle of consistency in quality and efficacy with the originator drugs. In other words, generic drugs must achieve a level of quality and efficacy that is consistent with the originator drugs. The purpose of conducting these consistency evaluations is to ensure that generic drugs are comparable to the originator drugs in terms of both quality and efficacy.
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