Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) bovine source heparin sodium raw materials and heparin sodium injection passed the Shandong Halal Certification Service Co., Ltd. (SHC) on-site audit according to MUI HAS23000 and MS1500:2009, and we received HALAL certificate issued by the agency recently. The relevant situation is announced as follows:
1. Basic information of drug certification
Certified products: Heparin Sodium API, Heparin Sodium Injection
Certification standard: MUI HAS23000 and MS1500:2009
Applicant: Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
HALAL certificate registration number: 03204928
2. Other conditions of medicines: Bovine heparin sodium is the sodium salt of aminodextran sulfate extracted from bovine intestinal mucosa or bovine lung, which belongs to mucopolysaccharides. It has the same effect with the current widely used porcine heparin sodium in the therapeutic effect. Bovine heparin sodium injection main uses:
(1) for the prevention and treatment of thrombosis or embolizing diseases (such as myocardial infarction, thrombophlebitis, pulmonary embolism, etc.)
(2) disseminated intravascular coagulation (DIC) caused by various reasons )
(3) It is also used in the operation of hemodialysis, extracorporeal circulation, catheterization, microvascular surgery and the anticoagulation treatment of certain blood specimens or instruments. HALAL certification is a qualification certification for Muslims to eat and use products. Currently, various countries agree with the MUI HAS23000 and MS1500:2009 halal certification standards. This certificate can be recognized by most Islamic countries.
3. Impact on the company and risk warning: The company has been developing bovine source heparin products since 2016. This time the bovine source heparin products have obtained HALAL certification, marking that it can enter the Muslim market of mutual recognition globally. The company will follow up the drug registration or filing process of the bovine source heparin series products in Muslim countries. At present, the series products have not yet been sold.
Post time: Jul-01-2020