Sodium Fusidate API
| CAS No. | 751-94-0 |
| Therapeutic Category | Antibiotic |
| Technology | Semi-Synthetic |
| Dosage Form | Cream/Injection |
| Innovator Brand | N/A |
| Registration Status | China: A, GMP 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:Sodium (3α,4α,5α,8α,9β,11α,13α,14β,16β,17Z)-16-acetoxy-3,11-dihydroxy-4,8,14-trimethyl-18-norcholesta-17,24-dien-21-oate
- Molecular Formula:C31H47NaO6
- Molecular Weight: 538.691
- Specification: EP/BP
- 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 Sodium Fusidate
Sodium fusidate is the more water-soluble sodium salt of fusidic acid, a steriodal metabolite of Fusidum coccineum which is a potent Gram-positive antibiotic. Fusidic acid inhibits protein synthesis in prokaryotes by inhibiting the ribosome-dependent activity of G factor and translocation of peptidyl-tRNA. Fusidic acid also suppresses NO lysis of pancreatic islet cells.
Why Choose Us as Your Manufacturer?
- Qingmu’s Sodium fusidate has been approved in China(DMF filed and listed on CDE’s website) with GMP and written confirmation, 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 remove factory. A new API factory is under design and is predicted to be put into use in 2025.
- 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.
- Qingmu, as a reliable Sodium Fusidate manufacturer, successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
