Oclacitinib Maleate API
| CAS No. | 1208319-27-0 |
| Therapeutic Category | Allergic |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Apoquel(USA) |
| Registration Status | R&D |
| Polymorph | Form A; Form B |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: Cyclohexanemethanesulfonamide, N-methyl-4-(methyl-3H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-, trans-, (2Z)-2-butenedioate (1:1)
- Molecular Formula: C19H27N5O6S
- Molecular Weight: 453.513
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- 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
- 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 Oclacitinib Maleate
- Oclacitinib is labeled to treat atopic dermatitis and itchiness (pruritus) caused by allergies in dogs, though it has also been used to reduce the itchiness and dermatitis caused by flea infestations. It is considered to be highly effective in dogs and has been established as safe for at least short-term use. Its efficacy equals that of prednisolone at first, though oclacitinib has been found to be more effective in the short term in terms of itchiness and dermatitis, long-term safety is unknown. It has been found to have a faster onset and cause fewer gastrointestinal issues than cyclosporine. While safe in the short term, oclacitinib’s long-term safety is unknown. While some say it is best only for acute flares of itchiness, others claim that it is also useful in chronic atopic dermatitis.
Why Choose Us as Your Oclacitinib Manufacturer?
- Qingmu is an Oclacitinib supplier. 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 of removing the 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, synthetic route development, scale-up & quality research.
- Our lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. We passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) and also customer audits from Europe, USA, Japan, etc.
- As an Oclacitinib manufacturer, Qingmu 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 you with the best quality products and services.
