As the world's leading hyaluronic acid researcher and producer, Bloomage Biotech’s raw material business has had a strong and stable performance, maintaining competitive advantages in the market. On Nov. 10th, 2022, in order to strengthen the supervision and management of medical sodium hyaluronate (“HA”) products, the National Medical Products Administration of China issued the Notice of the National Medical Products Administration on Management Categories of Medical Sodium Hyaluronate Products. Depending on their intended use and application fields, these products are classified into three categories: drugs, Class II medical devices, and Class III medical devices.
According to industry insiders, the issue of this NMPA’s specific guidance will result in more medical sodium hyaluronate products getting approved in China. This will effectively drive the growth of the raw material market of pharmaceutical grade sodium hyaluronate, and the market share of leading companies in the industry is thus expected to further increase.
Relying on the advantages of biological fermentation technology and industrialization, Bloomage Biotech's hyaluronic acid industrialization scale has always been at the forefront of the industry worldwide. Its HyatrueTM sodium hyaluronate as pharmaceutical grade raw material, which is fermented by Streptococcus zooepidemicus, is non-transgenic, free of animal-derived materials, and thus natural and safe. It also has the characteristics of high purity (the impurities such as nucleic acid and protein are far lower than the European Pharmacopoeia standards, and the actual level of endotoxin can even be lower than the detection limit of the test method) and high stability.
In addition, with its ability to produce HyatrueTM sodium hyaluronate with the molecular weight of 3 kDa to 3.5 MDa, Bloomage Biotech can precisely customize molecular weights of sodium hyaluronate according to customer's needs, meeting its application requirements in topical preparation, ophthalmology, dermal fillers, facial rejuvenation, intra-articular injection, and other medicines and medical devices.
Bloomage Biotech attaches great importance to the global industrial layout, and its production plants have passed the authorities’ on-site inspections in compliance US FDA’s cGMP and the China NMPA’s GMP. Also, it has registered or filed products in different countries including the European Union, the United States, China, South Korea, and Japan. At present, the company has more than 600 R&D talents, and with sales subsidiaries set up in the United States, France, Japan, and South Korea, it can provide customers with all-round product and technical services, and application solutions all around the world.
The fundamental reason why Bloomage Biotech has become a leading enterprise in the industry is the advantages of its pharmaceutical sodium hyaluronate raw materials and their uniqueness. In the context of accelerating its strategic layout of the raw materials business, Bloomage Biotech's international market share in the pharmaceutical raw materials market is also expected to continue growing and deepening rapidly.
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