Leflunomide Tablets10mg

Leflunomide Tablets 10mg Technical Specification:

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 10mg

Leflunomide Tablets 10mg is a disease-modifying antirheumatic drug (DMARD) widely prescribed to manage autoimmune conditions like rheumatoid arthritis. Unlike painkillers or anti-inflammatory drugs that treat only symptoms, Leflunomide works by suppressing the underlying immune response, reducing inflammation, swelling, and redness caused by autoimmune activity.

The active mechanism of Leflunomide involves blocking the action of chemical messengers responsible for inflammatory processes. This leads to the slowing of disease progression, ultimately protecting joint function and improving patients’ quality of life.

Globally, the demand for Leflunomide has increased due to:

• Rising prevalence of autoimmune diseases, especially rheumatoid arthritis

• Growing geriatric population

• Increasing awareness of long-term disease management

• Demand for cost-effective, high-quality generic medications

Taj Pharma, a leading Leflunomide Tablets 10mg manufacturer in India, has positioned itself as a reliable source for high-quality, globally compliant Leflunomide tablets.

In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma provides complete solutions for international pharmaceutical importers and distributors, ensuring seamless supply of Leflunomide Tablets 10mg.

✅ Regulatory Documentation Provided

Taj Pharma ensures international compliance with full documentation, including:

• WHO-GMP Certification

• EU-GMP Certification

• Certificate of Pharmaceutical Product (CoPP)

• CTD/eCTD dossiers for registration

• Certificate of Analysis (COA)

• Stability studies and shelf-life documentation

These documents facilitate easier approvals in international markets, including highly regulated countries.

✅ Custom Packaging & Labeling

• Blister packs, HDPE bottles, and bulk pharmaceutical packaging

• Multilingual labeling for global markets

• Tamper-proof and moisture-resistant export packaging

✅ Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablets

• Strength: 10mg

• Shelf-Life: 24–36 months depending on storage

• Storage: Store below 25°C, away from moisture and sunlight

✅ Export Certifications

• WHO-GMP certification ensures international quality standards

• EU-GMP certification for regulated European markets

• ISO 9001:2015 certified facilities

• COPP (Certificate of Pharmaceutical Product) for smooth import/export compliance

✅ Target Countries & Export Markets

Taj Pharma exports Leflunomide Tablets 10mg to numerous countries worldwide:

• Asia: Vietnam, Philippines, Bangladesh, Sri Lanka, Myanmar

• Middle East: UAE, Saudi Arabia, Oman, Qatar, Iraq

• Africa: Nigeria, Kenya, South Africa, Ghana, Egypt

• Europe & CIS: Russia, Ukraine, Kazakhstan

• Latin America: Brazil, Chile, Peru, Mexico

Why  is the Most Trusted Manufacturer, Supplier & Exporter

🌐 State-of-the-Art Manufacturing

Taj Pharma operates from Vapi, Gujarat, with modern WHO-GMP certified manufacturing units. Fully automated production lines and rigorous quality control ensure safe, consistent, and high-efficacy Leflunomide tablets.

💲 Affordable Pricing & Quality Assurance

Taj Pharma balances cost-effective pricing with stringent quality assurance, providing international distributors and hospitals with reliable and affordable Leflunomide tablets.

🚚 Global Presence & Supply Chain Support

• Trusted supplier to over 40 countries worldwide

• Efficient logistics, warehousing, and cold-chain management where necessary

• Regulatory support for registration in target markets

🌍 Top 20 Countries Exporting

1. USA

2. UK

3. UAE

4. Saudi Arabia

5. Nigeria

6. Kenya

7. South Africa

8. Vietnam

9. Philippines

10. Sri Lanka

11. Russia

12. Ukraine

13. Kazakhstan

14. Myanmar

15. Brazil

16. Peru

17. Chile

18. Oman

19. Qatar

20. Iraq

Technical Product Specification Table

If you are searching for a reliable Leflunomide Tablets 10mg manufacturer in India, Taj Pharma provides high-quality, WHO-GMP certified tablets for global distribution.

📞 Contact Taj Pharma today for price quotations, samples, or regulatory documentation.
🌐 Visit: www.tajpharma.com

Top 20 FAQs

Q1: What is Leflunomide Tablets 10mg used for?
A1: It is used to manage autoimmune diseases such as rheumatoid arthritis by reducing inflammation and slowing disease progression.

Q2: Who manufactures these tablets?
A2: Taj Pharma Ltd., Vapi, Gujarat, India, a WHO-GMP certified manufacturer.

Q3: Are these tablets exported internationally?
A3: Yes, Taj Pharma exports Leflunomide Tablets 10mg to over 40 countries.

Q4: Can Leflunomide be taken with food?
A4: Yes, it can be taken with or without food.

Q5: What are the common side effects?
A5: Nausea, headache, rash, diarrhea, respiratory tract infections, abnormal liver enzymes, and dyspepsia.

Q6: How should the tablets be stored?
A6: Store below 25°C in a dry place, away from direct sunlight.

Q7: Can distributors request custom packaging?
A7: Yes, multilingual and export-ready packaging is available.

Q8: Are stability studies and shelf-life documents provided?
A8: Yes, Taj Pharma provides complete documentation for regulatory submissions.

Q9: Can bulk orders be fulfilled?
A9: Yes, bulk orders for hospitals, distributors, and tenders are supported.

Q10: What regulatory certifications does Taj Pharma hold?
A10: WHO-GMP, EU-GMP, ISO 9001:2015, COPP, CTD/eCTD compliance.

Q11: Is Leflunomide safe for long-term use?
A11: When monitored by a physician, Leflunomide is safe for long-term therapy.

Q12: Are samples available for registration purposes?
A12: Yes, Taj Pharma provides samples for regulatory approval.

Q13: What dosage form is available?
A13: Tablets of 10mg strength.

Q14: How often should Leflunomide be taken?
A14: As prescribed by a physician, usually once daily.

Q15: Can Leflunomide be combined with other DMARDs?
A15: Only under medical supervision, as drug interactions may occur.

Q16: Does Taj Pharma provide export support documentation?
A16: Yes, full documentation for import/export registration is available.

Q17: Can PCD Pharma franchise opportunities be availed?
A17: Yes, Taj Pharma provides PAN India PCD Pharma Franchise.

Q18: What countries are primary export markets?
A18: UAE, Saudi Arabia, Nigeria, Kenya, Vietnam, Russia, Brazil, and more.

Q19: Does Leflunomide require regular monitoring?
A19: Yes, liver function tests and blood counts are recommended during therapy.

Q20: Why choose Taj Pharma?
A20: For high-quality WHO-GMP manufacturing, competitive pricing, global presence, and regulatory support.