Description

Leflunomide Tablets (10mg / 20mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Leflunomide Tablets in India. Leflunomide is a potent Disease-Modifying Antirheumatic Drug (DMARD) used for the treatment of active Rheumatoid Arthritis (RA) and Psoriatic Arthritis. Unlike simple painkillers (NSAIDs) that mask symptoms, Leflunomide actually slows down the progression of the disease and prevents structural damage to the joints.

We offer Contract Manufacturing (Third Party) services for this specialized immunosuppressant. Leflunomide has a very long half-life and potential for teratogenicity (birth defects). Therefore, our WHO-GMP certified facility in Mumbai utilizes dedicated containment zones and strict cleaning validation protocols to prevent cross-contamination with other products. Healthy Inc manages the export logistics, supplying rheumatology clinics and hospital chains across Europe, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Safety in handling and stability in release.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Containment Strategy: As a Category X drug (teratogenic), we manufacture Leflunomide in isolated suites with independent HVAC systems to protect our workers and other products from exposure.

  • Film Coating: We use a specialized moisture-protective film coating. This is critical because Leflunomide can degrade into its active metabolite (Teriflunomide) prematurely if exposed to humidity during storage.

  • Direct Compression: We utilize direct compression with specialized excipients (like colloidal silicon dioxide) to ensure good flow and uniform weight distribution of the 10mg/20mg dose.

• The Exporter: Healthy Inc

  • Child-Resistant Packaging: Given the severe risks if ingested by children or pregnant women, we prioritize child-resistant blister foils or bottle caps for export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for the specific degradation product (TFMA) to ensure stability and safety.

5. Why Use Leflunomide?

It stops the immune cells from multiplying out of control.

• Mechanism: Leflunomide is a Pyrimidine Synthesis Inhibitor. It inhibits the enzyme Dihydroorotate Dehydrogenase (DHODH) inside the mitochondria. Activated T-cells (which attack joints in Arthritis) need rapid pyrimidine synthesis to multiply. By blocking this enzyme, Leflunomide “starves” these immune cells, halting the autoimmune attack.

   

• Key Indications:

  • Rheumatoid Arthritis: Reduces joint swelling, pain, and stiffness; slows joint damage.

  • Psoriatic Arthritis: Improves both skin psoriasis and joint inflammation.

• Advantage: It is an effective oral alternative for patients who cannot tolerate Methotrexate.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Leflunomide Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Arava?

  A: Arava is the brand name (Sanofi). We manufacture the Generic Equivalent (Leflunomide), which is bioequivalent and cost-effective.

• Q: Can I get pregnant while taking it?

  A: ABSOLUTELY NOT. It causes severe birth defects. You must have a negative pregnancy test before starting and use strict birth control. If you plan to conceive, you must undergo a “Drug Elimination Procedure” (using Cholestyramine) to wash it out of your system, as it stays in the body for up to 2 years.

• Q: Does it cause hair loss?

  A: Yes. Mild hair thinning (alopecia) is a common side effect, but it is usually reversible after stopping the medication.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Loading Dose: 100mg once daily for 3 days (optional, often skipped to reduce side effects).

• Maintenance: 10mg or 20mg once daily.

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Hepatotoxicity: Can cause severe liver injury. Monitor Liver Enzymes (ALT/AST) monthly initially, then periodically. Avoid alcohol.

• Teratogenicity: Category X. Contraindicated in pregnancy.

• Hypertension: Can raise blood pressure. Monitor BP regularly.

• Diarrhea: A very common side effect (approx 20% of patients).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.