Lotilaner API
| CAS No. | 1369852-71-0 |
| Therapeutic Category | Anthelmintic |
| Technology | Synthetic |
| Dosage Form | Chewable tablets |
| Innovator Brand | Credelio |
| Registration Status | R&D |
| Polymorph | N/A |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- ChemicalName: 5 – [(5S) – 4,5 – dihydro – 5 – (3,4,5 – trichlorophenyl) – 5 – (trifluoromethyl) – 3 – isoxazolyl] – 3 – methyl – N – [2 – oxo – 2 – [(2,2,2 – trifluoroethyl)amino]ethyl] – 2 – thiophenecarboxamide
- Molecular Formula: C20H14Cl3F6N3O3S
- Molecular Weight: 596.76
- 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: To be defined
- Standard Package: 1kg/bag or according to the customer’s requirement
Applications of Lotilaner
- CREDELIO (lotilaner) is a beef-flavored, chewable tablet for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum lotilaner dosage of 9 mg/lb (20 mg/kg).
- CREDELIO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.
- Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders.
Why Choose Us as Your Lotilaner Supplier?
- Qingmu is a Leading Lotilaner Manufacturer, which manufactured under cGMP and can be supported for registration worldwide.
- 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 remove factory.
- Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes, synthetic route development, 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. We are committed to producing the best quality products.
- As a reliableLotilaner factory, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
