GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Leflunomide Tablets IP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Leflunomide IP……………..10mg
Excipients………………………q.s
Colour: Titanium Dioxide IP
2. Leflunomide Tablets IP 20mg
Each film-coated tablet contains:
Leflunomide IP…………….20mg
Excipients…………………..q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Protect from Light.
Dosage: As directed by the Physician
Leflunomide Tablets 20mg Technical Specification:
| Product Name: | Leflunomide Tablets IP |
| Brand Name: | Generic |
| Strength: | (10mg), (20mg) |
| Dosage Form: | Tablets(film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antirheumatic |
| Indication: | Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs). |
| Storage: | Store below 30 °C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Leflunomide Tablets IP 10mg
2. Leflunomide Tablets IP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Leflunomide Tablets IP 10mg
Each film-coated tablet contains:
Leflunomide IP……………..10mg
Excipients………………………q.s
Colour: Titanium Dioxide IP
2.Leflunomide Tablets IP 20mg
Each film-coated tablet contains:
Leflunomide IP…………….20mg
Excipients…………………..q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs).
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.
STORAGE & DOSAGE:
Storage: Store below 30°C.
Protect from Light.
Dosage: As directed by the Physician
Introduction to Leflunomide Tablets 20mg
Leflunomide Tablets 20mg are a prescription disease-modifying antirheumatic drug (DMARD) used to treat active rheumatoid arthritis (RA) and psoriatic arthritis. By suppressing overactive immune responses, leflunomide reduces joint inflammation, swelling, stiffness, and slows the progression of joint damage.
The global demand for DMARDs has increased due to the rising prevalence of autoimmune conditions and the need for effective, long-term management of rheumatoid arthritis and related disorders. As a trusted Leflunomide Tablets 20mg manufacturer in India, Taj Pharma ensures high-quality, affordable, and globally compliant medications for healthcare providers worldwide.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma simplifies international procurement by providing comprehensive regulatory support, including:
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WHO-GMP certification
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EU-GMP compliance
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Certificate of Pharmaceutical Product (COPP)
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CTD Dossiers for regulatory submissions
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Free Sale Certificates
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Batch-wise Certificate of Analysis (COA)
These documents ensure regulatory compliance, smooth customs clearance, and faster approval for importers in international markets.
Custom Packaging & Labeling
Taj Pharma offers fully customizable packaging options for global clients:
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Blister packs, strip packs, or bottles
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Multilingual labeling for export compliance
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Tamper-evident, high-quality packaging
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Private-label or PCD franchise branding options
Shelf-Life, Storage & Dosage Form
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Shelf-life: 24–36 months
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Dosage Form: Oral tablets, 20mg
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Storage: Store in a cool, dry place, away from sunlight and moisture
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Administration: Can be taken with or without food; follow physician’s prescription
Export Certifications
Taj Pharma adheres to international quality standards:
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WHO-GMP certified manufacturing units
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EU-GMP approved facilities
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ISO-certified quality management systems
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CTD dossiers for global regulatory approvals
Target Countries & Export Markets
Taj Pharma exports Leflunomide Tablets 20mg to over 70 countries across:
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Asia: Bangladesh, Sri Lanka, Vietnam, Philippines
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Africa: Nigeria, Kenya, Ghana, South Africa
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Middle East: UAE, Saudi Arabia, Oman, Qatar
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Europe & CIS: Ukraine, Kazakhstan, Georgia
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Latin America: Peru, Chile, Bolivia, Guatemala
Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter
1. State-of-the-Art Manufacturing
Taj Pharma’s facilities in Vapi, Gujarat are WHO-GMP and EU-GMP certified, using cutting-edge machinery, automated production lines, and stringent quality control protocols. Each batch undergoes rigorous purity, stability, and potency testing.
2. Affordable Pricing & Quality Assurance
Combining cost-effective production with premium quality control, Taj Pharma offers competitive pricing for distributors, hospitals, and international clients without compromising on drug efficacy.
3. Global Presence & Supply Chain Support
With an extensive logistics network, Taj Pharma ensures timely delivery of Leflunomide 20mg tablets worldwide. Their supply chain maintains drug integrity during transit and meets international standards.
4. Top 20 Countries Exporting
Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia
Technical Product Specification Table
| Parameter | Details |
|---|---|
| Product Name | Leflunomide Tablets 20mg |
| Active Ingredient | Leflunomide 20mg |
| Therapeutic Class | DMARD / Immunosuppressant |
| Indications | Rheumatoid arthritis, Psoriatic arthritis |
| Dosage Form | Oral tablets, 20mg |
| Shelf Life | 24–36 months |
| Packaging | Blister packs, strip packs, bottles |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
Call to Action for Buyers/Distributors
For businesses seeking a reliable Leflunomide Tablets 20mg manufacturer in India, Taj Pharma offers:
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WHO-GMP certified, high-quality tablets
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Export-ready packaging and labeling
-
Private-label PCD franchise options
-
Affordable bulk pricing
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Timely logistics and global supply chain support
📩 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Top 20 FAQs
Q1. What is Leflunomide Tablets 20mg used for?
A: To treat active rheumatoid arthritis and psoriatic arthritis by reducing joint inflammation.
Q2. Who is the leading manufacturer in India?
A: Taj Pharma is the most trusted manufacturer, exporter, and supplier.
Q3. How does Leflunomide work?
A: It suppresses overactive immune cells responsible for joint swelling and inflammation.
Q4. Can it cause side effects?
A: Yes, including breathlessness, dry cough, jaundice, severe itching, rash, dark urine, fever, and infections.
Q5. What is the shelf life?
A: 24–36 months under recommended storage conditions.
Q6. Can it be exported internationally?
A: Yes, Taj Pharma exports to over 70 countries.
Q7. Are WHO-GMP and EU-GMP certificates available?
A: Yes, all batches are certified.
Q8. Can it be taken with food?
A: Yes, it can be taken with or without food.
Q9. How should it be stored?
A: In a cool, dry place away from sunlight and moisture.
Q10. Are COA and stability certificates provided?
A: Yes, each batch includes a Certificate of Analysis.
Q11. Is it suitable for PCD franchise?
A: Yes, Taj Pharma provides franchise options for distributors.
Q12. Can packaging be customized for export?
A: Yes, multilingual labels and private-label options are available.
Q13. How to place bulk orders?
A: Contact Taj Pharma via email or website for quotations.
Q14. What are common severe side effects?
A: Rarely, liver toxicity, infections, or respiratory issues may occur; immediate medical attention is recommended.
Q15. Is it suitable for long-term treatment?
A: Yes, under physician supervision for chronic autoimmune conditions.
Q16. Can it interact with other medications?
A: Yes, consult your doctor regarding all current medications.
Q17. Can it be supplied for government tenders?
A: Yes, Taj Pharma complies with global tender requirements.
Q18. Is Leflunomide safe for pregnant women?
A: No, it is contraindicated in pregnancy and requires strict medical guidance.
Q19. How long does it take to show effect?
A: Clinical improvement may take several weeks; continuous use is recommended.
Q20. What quality assurance measures are followed?
A: Each batch undergoes rigorous QC testing, validated processes, and compliance with GMP standards.






