Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredient (API)
USP / BP / EP (as applicable)
Leflunomide
C₁₂H₉F₃N₂O
~270.2 g/mol
75706-12-6
5-methyl-N-[4-(trifluoromethyl)phenyl]-isoxazole-4-carboxamide
Isoxazole derivative; immunomodulatory agent
Disease-modifying antirheumatic drug (DMARD)
| Appearance | White to off-white crystalline powder |
|---|---|
| Solubility | Practically insoluble in water; soluble in DMSO, ethanol, and methanol |
| Melting Point | 155–158°C |
| pH | - |
Leflunomide is an immunomodulatory and anti-inflammatory agent used primarily to treat rheumatoid arthritis and other autoimmune conditions. It works by inhibiting dihydroorotate dehydrogenase (DHODH), a key enzyme in pyrimidine synthesis, which reduces the proliferation of activated lymphocytes. Leflunomide is orally active, has good bioavailability, and is often used as a long-term disease-modifying therapy.
Leflunomide works by inhibiting dihydroorotate dehydrogenase (DHODH), a key enzyme in the pyrimidine biosynthesis pathway, which reduces the proliferation of activated T- and B-lymphocytes. This action provides significant anti-inflammatory effects and helps modulate autoimmune responses, while exhibiting minimal direct cytotoxicity to other human cells at therapeutic doses.
| Attribute | Why Salius Pharma Is a Good Choice |
|---|---|
| Quality Certification | WHO GMP, ISO 9001:2015, FDA audited facilities |
| Affordability & Generic Access | Cost competitive generics for global supply |
| Export Experience | Proven track record of supplying globally |
When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.
We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.
7 to 21 business days from dispatch, depending on your location.
Leflunomide is generally stable in its crystalline form. No significant polymorphic changes have been reported under standard storage and processing conditions.
Leflunomide API is typically packed in 25 kg fiber drums with double/triple poly liners. HDPE drums or laminated bags can be used for humid climates or export shipments to ensure moisture protection.
Yes, Leflunomide melts at 155–158°C, which aligns with pharmacopeial standards. This ensures batch consistency and confirms identity and purity.
Leflunomide is moderately free flowing in powder form. For high-speed tablet compression or capsule filling, addition of glidants may be recommended to improve flow.
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