Firocoxib API
| CAS No. | 189954-96-9 |
| Therapeutic Category | Anti-Inflammatory |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Equioxx, Previcox(USA) |
| Registration Status | US: VMF006292 Others: VMF |
| Polymorph | Form B |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description of Firocoxib API
- Grade: pharmaceutical grade
- Chemical Name:3-(Cyclopropylmethoxy)-5,5-dimethyl-4-(4-(methylsulfonyl)phenyl)furan-2(5H)-one
- Molecular Formula: C17H20O5S
- Molecular Weight: 336.403
- Specification: In-house established according to ChP/USP/EP
- Appearance: White to off white crystalline powder
- Solubility: Soluble in ethyl acetate and acetonitrile, slightly soluble in ethanol, and insoluble in water.
- Total impurities: not more than 2.0%
- Purity: not less than 98%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8, report available, included in DMF
- Nitrosamine assessment: nitrosamine assessmemt report available which also included in DMF
- Particle size: regular grade or milling/sieving according to customer’s requirement.
- Storage: Store in an airtight container below 25°C.
- Production capacity: 5 tons per year
- Batch size: 100kg/batch
- Standard Package: 1kg/bag, 5kg/bag, 10kg/bag or according to the customer’s requirement.
Applications of Firocoxib API
- Firocoxib API is a widely used non-steroidal anti-inflammatory raw material for veterinary medicine. With stable chemical properties and high absorption rate, it is favored by pharmaceutical factories and formulation manufacturers around the world.
- Firocoxib API is a selective inhibitor of COX-2 (IC50s = 0.13 and 7.5 μM for COX-2 and COX-1, respectively, in isolated cat blood). It inhibits LPS-induced production of prostaglandin E2 (PGE2; ) in isolated dog, horse, and cat whole blood ex vivo. Firocoxib decreases lameness, induces analgesia, and improves range of motion in dogs and horses with osteoarthritis when administered at doses of 5 and 0.1 mg/kg per day, respectively. Formulations containing firocoxib have been used in dogs and horses with osteoarthritis.
- Firocoxib API sold under the brand names Equioxx and Previcox among others, is a nonsteroidal anti-inflammatory drug of the COX-2 inhibitor (coxib) class, approved for use in horses (Equioxx) and for use in dogs (Previcox). Firocoxib is the first COX-2 inhibitor approved by the U.S. Food and Drug Administration for horses. Firocoxib is not intended or approved for use in human medicine.
- Firocoxib API was approved for veterinary use in the United States for dogs in July 2004 and for horses in July 2016. Firocoxib is available as a generic medication for horses and for dogs.
Why Choose Us as Your Firocoxib Manufacturer?
- Qingmu is a USFDA certified Firocoxib API factory in China. For our Firocoxib API, 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.
- 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 Firocoxib API manufacturer, successfully exported our products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. We are always ready to provide customers with the best quality products and services.
