Bisoprolol Fumarate API
| CAS No. | 104344-23-2 |
| Category | Cardiovascular |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Concor(USA) |
| Registration Status | China: A, GMP, Written Confirmation EU: CEP 2016-139 Japan: 230MF10053 Others: DMF |
| Polymorph | N/A |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name:1-(4-{[2-(1-methylethoxy)ethoxy]methyl}phenoxy)-3-[(1-methylethyl)amino]propan-2-ol (2E)-but-2-enedioate (2:1) (salt)
- Molecular Formula:C40H66N2O12
- Molecular Weight:766.96
- Specification: ChP/USP/EP/BP/JP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade and customized grade
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Bisoprolol Fumarate
- Bisoprolol Fumarate is the fumarate salt of a synthetic phenoxy-2-propanol-derived cardioselective beta-1 adrenergic receptor antagonist with antihypertensive and potential cardioprotective activities.
- Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long half-life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs. Bisoprolol is generally well tolerated, likely due to its β1-adrenergic receptor selectivity, and is a useful alternative to non-selective β-blocker drugs in the treatment of hypertension such as Carvedilol and Labetalol. It may be used alone or in combination with other drugs to manage hypertension and can be useful in patients with chronic obstructive pulmonary disease (COPD) due to its receptor selectivity.
- In recent years, bisoprolol fumarate is also tempted used for the treatment of heart failure. It is effective for moderate to severe chronic stable heart failure which previously received ACE inhibitors, diuretics, and cardiac glycoside medications associated with ventricular systolic dysfunction (ejection fraction ≤35%).
Why Choose Us as Your Bisoprolol API Manufacturer?
- As a Bisoprolol supplier, Qingmu’s Bisoprolol has been approved in China(DMF filed and listed on CDE’s website), and also got the CEP certificate in EDQM and filed in Japan PMDA, DMF in CTD format is available and can be supported for registration worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to removing the factory. A new API factory is under design and is predicted to be put into use in 2025. Please feel free to choose us.
- Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
- This China Bisoprolol manufacturer successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. We are always ready to provide the best quality products and services to you.
- As a bisoprolol manufacturer, we aim to create a healthy world by providing essential active pharmaceutical ingredients for humans.
