Changshan Pharmaceutical Co., Ltd. announced on the evening of May 6 that the company's heparin sodium from cattle and heparin sodium injection have passed the on-site audit conducted by the Halal certification body in accordance with MUI HAS23000 and MS1500:2009 standards, and obtained the Halal certificate, which will allow the products to be sold to the globally recognized Muslim market.
Gao shuhua, founder of changshan pharmaceutical company, said that in order to ensure the company's long-term and rapid development, changshan pharmaceutical company has always attached great importance to research and development, the company has done a good job of bovine heparin related technology and products. He said the company is currently developing low-grade heparin from cattle and expects it to be available in a year or two.
According to relevant agencies, the global market space of heparin from cattle is estimated to be 2 billion to 3 billion US dollars. After Changshan Pharmaceutical has obtained the HALAL certification, it will be recognized by more than 40 countries or regions around the world, which means that Changshan Pharmaceutical has successfully obtained the ticket to enter the global Muslim market.
It is understood that because Changshan Pharmaceutical Co., Ltd is in the leading position in the research and development and production of pig heparin preparations in China, plus the earlier layout in the research and development of bovine heparin, Changshan Pharmaceutical Co., Ltd. Bovine heparin raw materials and preparations in the international market will have strong technical advantages, high product quality, fast product launch and other competitive advantages. In terms of technological superiority. The technology of Changshan Pharmaceutical has passed the virus inactivation verification of French virus laboratory Texcell. It is understood that the virus inactivated validation process, is the first of five kinds of viruses to be detected is added to the raw materials (including "mad cow disease" prions), after dichroa pharmaceutical process, to get the content of material to be detected virus detection, verification results can be effectively eliminated the virus, dichroa technology pass validation. In addition, the company has obtained the Halal certificate, the products can be sold to Malaysia, India, Pakistan and other countries, the Middle East Gulf region and the international Muslim market. In the future, the company will accelerate the registration or filing of bovine heparin drugs in Muslim countries. At present, bovine heparin preparations have been sold in Indonesia and other places, so the subsequent products can enter the market faster.
It is understood that there are no domestic enterprises engaged in the production of bovine heparin raw materials and preparations. There are a small number of foreign bovine heparin manufacturers: Brazil Extrasul, the bulk drug company of bovine heparin; Malaysia's Ain Medicare Sdn. Bhd., India's PT. Pratara Nirmala and other companies have only bovine heparin formulations, and their API is imported from Brazil.
It is known that heparin is a kind of glucosaminoglycan widely existed in animal organs and tissues (such as small intestine mucosa, lung, etc.), which has many biological functions such as anti-coagulation, anti-inflammation, anti-allergy, antivirus, anti-cancer, regulating blood lipid and so on. In medicine, it is often used as mucopolysaccharide sulfate anticoagulant. Like most mucopolysaccharides, heparin mostly exists in the form of heparin-protein complex in animals. However, heparin products are all natural heparin and its compounds, which cannot be completely synthesized artificially.
Dichroa pharmaceutical industry as early as 2016 NiuYuan heparin project, launched in early 2018 with the French Turk cernet co., LTD. (Texcell) cooperation, based on the characteristics of heparin sodium production process of the key steps, take the lead in the industry for NiuYuan heparin sodium API virus cleaning validation (inactivated), conducted among 5 kinds of virus removal (inactivated) authentication, These include prions (mad cow disease).
