Hubei Biocause Heilen Pharmaceutical Co., Ltd.

Company Profile

1) Product R&D process Product research and development strength is the core competitiveness of the company, is the cornerstone to expand domestic and overseas markets, is the guarantee to continue to rapidly development in the future. The company's core technology and competitiveness of R&D are mainly reflected in the following aspects: First, constantly innovates and improves on the existing technology of ibuprofen API, such as transforming the reaction system of ibuprofen ketone; Optimize multiple nodes of the ibuprofen recovery unit (such as neopentyl glycol recovery and utilization, aluminum trichloride recovery and production of water purifier, etc.); The crystallization process and particle size control process of ibuprofen were improved, so as to continuously optimize the production process of ibuprofen, reduce the production cost of ibuprofen, and further exert its scale advantage. Secondly, we researched and developed a series of ibuprofen derived API products ,such as S-ibuprofen, ibuprofen lysine, ibuprofen sodium, ibuprofen Grade 350 and etc., which not only meets the different demand of existing domestic and overseas customers, but also helps to expand new customers and markets. Thirdly, on the core basis of non-steroidal anti-inflammatory drugs ,we have actively researched and developed anti-tumor, cardiovascular and other characteristic apis, such as abiraterone acetate, fludarabine phosphate, Torasemide, Milinone and etc., to enrich the company's product line and increase the thickness of operating profit. Finally, the company has gradually promoted the research and development work of consistency evaluation of formulation products. At the same time, based on the existing formulation, we also actively researched and developed more dosage forms, such as slow-release capsule type, enteric-soluble capsule type, etc. 2) Production aspect After years of accumulation of experience in the production of chemical synthetic drugs and innovation in technological process research and development, the company has developed into a modern chemical raw material and formulation production and manufacturing enterprise characterized by completed equipments, exquisite craftsmanship, strong industrialization ability, and standardized quality control. The core technology and competitiveness of the company in production are mainly reflected in the following aspects: firstly, the company continuously updates and transforms equipment to make the production process more standardized, intelligent, and automated. Secondly, the company strictly adheres to Chinese drug GMP standards as well as drug standards and concepts in countries and regions such as Europe, America, Japan, and South Korea. It has established a comprehensive quality management system and strictly implements it. The operating procedures documentation of production standard covers various links such as production, materials, equipment and facilities, inspection, packaging and labeling, quality assurance, etc. Finally, the company continues to innovate and improve its existing product process routes, boldly attempting to innovate and break through patent paths. The design of the company's production process takes into account the recycling of raw materials and the recycling of by-products, improving the efficiency of the company's production and operation, thereby controlling production costs. Relying on the advantages in product production, the company has formed a certain scale advantage in ibuprofen's subdivided products, and has a certain position in the global competition, which can provide a stable source of income and profit for the company. 3) Product registration If one API manufacturer wants to become one qualified supplier of the downstream formulation manufacturer, which not only obtains drug registration and certification issued by drug regulatory authorities of each importing country, but also must accept very strict audit from formulation manufacturer. The core technology and core competitiveness of the company in the product registration are mainly reflected in the following aspects: First, The company has passed new national GMP certification for domestic registration and certification, which has obtained domestic registration approval license of 52 drugs, such as Ibuprofen, Dexibuprofen Torasemide, Second, the company has received site inspection from FDA and EDQM and different authority for overseas registration. The products have been sold to more than 80 countries worldwide; last, The company with its high-quality product and strict quality control system has been successfully registered as one global qualified supplier of many pharmaceutical giants, Such as Sanofi, GlaxoSmithKline, Abbott, Pfizer, Johnson & Johnson, Teva Pharmaceutical, Sun Pharmaceuticals, Granules-India and etc, Also Company has enjoyed high popularity and reputation in regular markets such as USA, EU and Japan. 4) Integration of API and formulation At present, the company has formed an integrated industrial chain layout with API and formulations. Company core technology and core competitiveness in the integration of API and formulations are mainly reflected in the following aspects: First, company formulations are mainly produced by own APIs, and production capacity, quality and supply of APIs can achieve self-guarantee, which can avoid being constrained by upstream suppliers. The large-scale production of API can also reduce production cost of formulations; second, the company will extend the products to downstream field to improve the diversity of business and enjoy more value in the industrial chain, and enhance the ability to resist market risks; Finally, with the comprehensive implementation of the procurement for generic drugs and the centralized procurement of key generic drugs, the sales advantage of single formulation sells in the field of generic drugs and its brand advantage will be decreased as the promotion of generic name. The integration of API + formulation is expected to enable the company to occupy a high market position through scale advantage, cost control and quality control.