Composition: Each film-coated tablet contains Leflunomide BP 20 mg.
Usage: Treatment of active rheumatoid arthritis in adults.
Category: Disease-Modifying Antirheumatic Drugs (DMARDs)
Therapeutic category: Immunomodulator / DMARD
SKU: Leflunomide Tablets
Manufacturer: Healthy Life Pharma Pvt. Ltd. (as supplied)
Exporter: Healthy Inc (as supplied)
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Leflunomide Tablets BP – Manufacturer, Supplier & Exporter is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Leflunomide Tablets BP 20 mg
Healthy Life Pharma Pvt. Ltd. is listed as the manufacturer and Healthy Inc as the exporter of Leflunomide Tablets. Leflunomide is a prescription disease-modifying antirheumatic drug (DMARD) used for adults with active rheumatoid arthritis. Unlike pain relievers, it acts on the immune response to help reduce disease activity and slow joint damage.
The supplied product composition confirms Leflunomide BP 20 mg in a film-coated tablet. Contract manufacturing, destination-market supply, facility certifications and availability of additional strengths should be confirmed with the manufacturer.
| Product name | Leflunomide Tablets |
|---|---|
| Composition | Each film-coated tablet contains Leflunomide BP 20 mg |
| Strength confirmed | 20 mg (10 mg mentioned in description but not confirmed in supplied composition) |
| CAS number | 75706-12-6 |
| Dosage form | Film-coated tablet |
| Pharmacopoeial standard | BP stated for supplied 20 mg formulation; other standards require verification |
| Therapeutic class | Conventional synthetic DMARD / Immunomodulator |
| Indication | Active rheumatoid arthritis in adults, subject to local authorization |
| Shelf life / Packaging | Confirm from approved product label and stability data |
| SKU | Leflunomide Tablets |
Manufacturing considerations include suitable containment and exposure controls, validated blending and compression, film-coating consistency, stability, and packaging protection. Actual processing methods, dedicated facilities, HVAC configuration, excipients and child-resistant packaging must be verified from the approved manufacturing records; these are not established by the supplied composition.
Product release testing should follow the applicable approved BP specification and validated methods for identity, assay, content uniformity, dissolution, related substances, microbial quality where applicable, and stability. Specific dissolution limits, assay ranges and shelf life must not be assumed without the applicable monograph, registration dossier and batch documentation.
Leflunomide is converted to its active metabolite, teriflunomide, which inhibits dihydroorotate dehydrogenase (DHODH), reducing de novo pyrimidine synthesis and proliferation of activated lymphocytes. It is used as a DMARD in active rheumatoid arthritis. Use in psoriatic arthritis depends on local approvals and specialist assessment; it should not be presented as universally approved.
Correction: Leflunomide is not an antiarrhythmic; its therapeutic category is DMARD / immunomodulator.
For business enquiries, request the destination-country product registration status, current manufacturing authorization, GMP evidence, batch certificate of analysis, approved labeling, stability data and applicable CTD/ACTD documentation. Availability of FSC, COPP, dossiers, bioequivalence studies and shipping terms should be confirmed directly with Healthy Life Pharma Pvt. Ltd. or Healthy Inc.
Q: What is Leflunomide used for?
A: It is a prescription DMARD for adults with active rheumatoid arthritis.
Q: Is 10 mg available?
A: The submitted product composition confirms only Leflunomide BP 20 mg. A 10 mg strength is referenced in marketing copy but needs confirmation.
Q: Is Leflunomide safe during pregnancy?
A: No. It can cause serious fetal harm. Pregnancy must be excluded before starting therapy and effective contraception is required. A clinician may prescribe an accelerated drug-elimination procedure before planned pregnancy.
Q: Is it the same as Arava?
A: Arava is a branded leflunomide product. Pharmaceutical equivalence or bioequivalence for this particular product must be demonstrated, not assumed.
Dose selection and any loading regimen must follow the locally approved prescribing information and the treating rheumatologist's assessment. A commonly used adult maintenance regimen is 20 mg once daily, with dose adjustments in some patients. Do not start, change or stop treatment without medical supervision. Because the active metabolite persists for a long time, an accelerated elimination procedure may be necessary in pregnancy planning or serious toxicity.
Seek urgent medical care for jaundice, severe rash, breathing difficulty, signs of infection, or suspected pregnancy.
Store in the original packaging, protected from moisture and out of children's reach. Follow the temperature and storage conditions stated on the approved pack label; the supplied material does not establish a verified product-specific limit.