HNSP received Drug Registration Approval for Bivalirudin

一、Hainan Shuangcheng Pharmaceuticals Co.,Ltd. has received the Drug Registration Approval Letter for Bivalirudin forInjection from National Medical Products Administration and the Letter numberis 2019S00024:

1、Drug approvalnumber: National Drug Approval Number (GUOYAOZHUNZI) H20193019

2、Product name:Zhusheyong Bifaluding

3、English name: Bivalirudinfor Injection

4、Dosage form:Injection

5、Strength: 250 mg

6、Manufacturer:Hainan Shuangcheng Pharmaceuticals Co., Ltd.

7、Manufacturingsite: No. 16 Xingguo Road, Xiuying District, Haikou City, Hainan Province

8、Application item: Nationaldrug registration

9、Registrationcategory: Category 6 of Chemical Drugs

10、Approval date: January15 2019

11、Expiration date of drug approval numb er: January 14 2024

二、In June 2018, Hainan Shuangchengreceived Tentative Approval from USFDA for Bivalirudin for Injection, and theANDA number is 210031.

Bivalirudinis a direct thrombin inhibitor used to prevent coagulation of blood. And theUSFDA approved indications of Bivalirudin for Injection are: indicated for useas an anticoagulant in patients undergoing percutaneous transluminal coronaryangioplasty (PTCA); indicated for use as an anticoagulant in patientsundergoing percutaneous coronary intervention (PCI); indicated for patientswith, or at risk of Heparin Induced Thrombocytopenia (HIT) or Heparin InducedThrombosis-Thrombocytopenia Syndrome (HITTS) undergoing PCI.