OMadacycline tosylate API
| CAS No. | 1075240-43-5 |
| Therapeutic Category | Antibacterial |
| Technology | Synthetic |
| Dosage Form | Injection/Tablets |
| Innovator Brand | NUZYRA(USA) |
| Registration Status | Technical Package |
| 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: 10,11-Dihydro-11-oxodibenzo[b,f][1,4]thiazepinerhydrate;Niraparib TsOH salt hydrate
- Molecular Formula: C36H48N4O10S
- Molecular Weight: 510.605
- Specification: Enterprise Standard established according to ChP/USP/EP
- 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 or milling/sieving according to customer’s requirement.
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of OMadacycline tosylateOMadacycline tosylate API
- NUZYRA(OMadacycline tosylate) is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
- Community-acquired bacterial pneumonia (CABP)
- Acute bacterial skin and skin structure infections (ABSSSI)
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA(OMadacycline tosylate) and other antibacterial drugs, NUZYRA(OMadacycline tosylate) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Why Choose Us as Your OMadacycline tosylate Supplier?
- Qigmu is a OMadacycline tosylate supplier in China. Our 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.
- 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, Japan, etc.
- As a reliable OMadacycline tosylate API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
