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Hybio Pharmaceutical Co., Ltd.: Peptide manufacturers compliant with FDA, AEMPS, ANVISA, MFDS

Release time：2024-10-04 12:34:43 Source：DuHao

Tel : +86-0755-26588033

Email: net.fei@163.com

Address: No. 7, Guansheng 4th Rd,Guanlan High- Tech Park, Longhua District, Shenzhen, Guangdong 518110, P.R. China

Hybio Pharmaceutical Co., Ltd., established in April 2003, stands as a pioneering force in the field of peptide pharmaceuticals. Recognized as a national high-tech enterprise, Hybio specializes in the research, production, and sales of peptide-based medicines. In 2011, the company marked a significant milestone by being listed on the Shenzhen Stock Exchange (stock code: 300199), distinguishing itself as the first peptide enterprise to achieve such a status in China.

With its headquarters in Shenzhen and several subsidiaries across Pingshan, Wuhan, Hong Kong, Gansu Chengji, and Dali, Hybio operates extensively in the pharmaceutical and medical device sectors. Its product offerings encompass a diverse range of peptide raw materials, custom peptides, cosmetic peptides, peptide formulations, solid dosage forms, and peptide skincare products.

Regulatory Excellence

Hybio has established a robust foundation in regulatory compliance, attaining Good Manufacturing Practice (GMP) certifications from various international authorities, including the NMPA (CFDA) of China, the US FDA, the EU's AEMPS, Brazil's ANVISA, and South Korea's MFDS. The company boasts impressive accomplishments, including:

9 New drug certificates
23 Clinical approvals
7 GMP certificates in China, covering 13 APIs, injectable, and solid dosage forms
25 Approval certificates for peptide finished formulations

Overview and Strategic Vision

Hybio’s dedication to excellence is reflected in its comprehensive product pipeline, which includes therapeutic applications in diabetes mellitus, obstetrics and gynecology, cardiovascular health, gastroenterology, immunology, neurology, and skincare. The company's commitment to adhering to US FDA and EU cGMP standards is supported by a strong regulatory and quality team, ensuring that products meet the highest international standards.

With over a decade of experience in global market development, Hybio has cultivated a robust sales and marketing network across mainland China. The company is driven by a people-oriented culture that emphasizes customer-centricity, innovation, and pragmatic cooperation.

Mission and Corporate Spirit

At the core of Hybio’s operations lies the philosophy "the way of the world, benevolence as medicine." This guiding principle underscores the company's commitment to enhancing life through affordable medical solutions while maintaining the highest standards of quality and integrity. With a focus on scientific and technological innovation, Hybio has attracted a team of highly qualified professionals, including postdoctoral and doctoral graduates, fostering a dynamic environment that propels the company toward continued growth and success.

Research and Development Excellence

Hybio’s commitment to research and development is exemplified by its extensive R&D team, comprising over 203 researchers, who are instrumental in driving the company's innovation. Collaborations with over 30 scientific research institutions have enriched Hybio's capabilities, while the company proudly holds 277 Chinese patents and 30 global patent authorizations. With a strategic focus on independent technological innovation, Hybio has achieved remarkable economic growth, with key financial indicators doubling over the past three years.

Advanced Manufacturing Capabilities

Hybio is equipped with the most advanced fully automatic peptide synthesis and purification systems, alongside production lines for small-volume injections, freeze-dried powder injections, tablets, hard capsules, and granules. This state-of-the-art infrastructure supports the production of over 40 varieties of preparations and APIs, including notable peptide drugs such as salmon calcitonin injection and desmopressin acetate injection. Hybio's commitment to quality is reflected in its rigorous adherence to international standards, with certifications from US cGMP, EU GMP, Korean GMP, and other global benchmarks.

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