Shandong Xinhua Pharmaceutical Co., Ltd.
Announcement on Obtaining the Drug Registration Certificate for Bumetanide Injection
This announcement is made to ensure the truthfulness, accuracy, and completeness of the information provided by the company and its staff.
Recently, Shandong Xinhua Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinhua Pharmaceutical" or "the Company") received the drug registration certificate for Bumetanide Injection (hereinafter referred to as "the Product") from the National Medical Products Administration. The relevant situation is announced as follows:
I. Basic Information
| Drug Name | Bumetanide Injection |
|---|---|
| Test Type | Injection |
| Specifications | 2ml: 0.5mg; 4ml: 1mg |
| Drug Category | Prescription Drug |
| Application Type | Class 3 Prescription |
| Applicant | Shandong Xinhua Pharmaceutical Co., Ltd. |
| Application Item | Drug Registration (Domestic Production) |
| Receipt Number | CIYH2401640, CIYH2501239, CIYH2401641, CIYH2501238 |
|---|---|
| Drug Approval Number | H20263884, H20263885 |
Approval Note: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, this product meets the requirements for registration. The product's registration number, quality standards, description, and labeling are in accordance with the relevant regulations. The production enterprise complies with the requirements for the production of the product.