Etodolac Extended-release Tablets 400mg

Etodolac Extended-release Tablets 400mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Etodolac Extended-release Tablets USP 400mg
B) Etodolac Extended-release Tablets USP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Etodolac Extended-release Tablets USP 400mg
Each film coated extended-release tablet contains:
Etodolac USP…………….400mg
Excipients……………………q.s
Colour: Lake of Erythrosine

B) Etodolac Extended-release Tablets USP 600mg
Each film coated extended-release tablet contains:
Etodolac USP………………600mg
Excipients……………………q.s
Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Etodolac is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body’s production of certain natural substances that cause inflammation.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight and light resistant container.
Dosage: As directed by the Physician

Introduction to Etodolac Extended-release Tablets 400mg

Etodolac Extended-release Tablets 400mg is a non-steroidal anti-inflammatory drug (NSAID) primarily used for pain relief and inflammation reduction. Its major applications include rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders. By blocking chemical messengers that cause inflammation and pain, Etodolac helps patients regain mobility and comfort.

The global demand for NSAIDs like Etodolac is steadily increasing due to the rising prevalence of arthritis, musculoskeletal conditions, and chronic pain. This has created a growing market for reliable pharmaceutical suppliers who can ensure consistent quality and international compliance.

Taj Pharma, as a trusted Etodolac Extended-release Tablets 400mg manufacturer in India, provides high-purity, WHO-GMP-certified tablets that meet the stringent quality standards of international markets.

Therapeutic Benefits and Usage

Etodolac Extended-release Tablets 400mg offers several benefits:

• Relieves pain and inflammation in chronic conditions

• Improves joint function and mobility

• Reduces stiffness and swelling associated with arthritis

Dosage and Administration

• Typically taken once or twice daily, depending on medical advice

• Take with food or milk to reduce the risk of stomach irritation

• Swallow tablets whole; do not crush or chew

Common Side Effects

Though generally well-tolerated, Etodolac may cause:

• Nausea and vomiting

• Dizziness and headache

• Diarrhea or heartburn

• Abdominal discomfort and flatulence

Patients are advised to follow medical guidance and report any unusual symptoms promptly. Taj Pharma ensures clear labeling and usage instructions to maximize safety and effectiveness.

Details for Importers and Exporters

Regulatory Documentation Provided

Taj Pharma supplies comprehensive documentation to support global trade:

• WHO-GMP Certification

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier for registration

• Certificate of Analysis (COA)

• Stability and analytical reports

Custom Packaging & Labeling

• Blister packs with protective Alu-Alu layers

• Multi-language labeling for international compliance

• Private labeling for distributors and PCD partners

Shelf-life & Storage

• Shelf Life: 24–36 months

• Storage Conditions: Store below 25°C in a dry place, away from sunlight

Dosage Form

• Extended-release tablets designed for once or twice daily dosing

Export Certifications

• WHO-GMP

• ISO 9001:2015

• EU-GMP Certification (for select markets)

• COPP and CTD Dossier

Target Export Markets

Taj Pharma exports Etodolac Extended-release Tablets 400mg to over 40 countries, including:

Vietnam, Kenya, Nigeria, South Africa, UAE, Oman, Sri Lanka, Nepal, Bangladesh, Iraq, Yemen, Russia, Peru, Colombia, Chile, Ghana, Tanzania, Mauritius, Myanmar, Philippines.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

Taj Pharma’s facilities in Vapi, Gujarat are WHO-GMP-certified, equipped with modern machinery, and follow stringent quality control protocols. Every batch undergoes rigorous testing for potency, purity, and bioavailability.

2. Affordable Pricing and Quality Assurance

Taj Pharma combines cost-efficient production methods with strict quality checks, providing competitive pricing without compromising international standards.

3. Global Presence and Supply Chain Support

Taj Pharma ensures:

• Timely international deliveries

• Regulatory assistance for import registration

• Flexible order quantities for distributors

• Market support for PCD pharma partners

4. Top 20 Exporting Countries

UAE || Saudi || Arabia || Oman || Qatar || Kuwait || Nigeria || Kenya || Ghana || South Africa || Egypt || Germany || France || UK || Italy || Spain || Sri Lanka || Myanmar Malaysia || Philippines || Vietnam

Technical Product Specification Table

Call to Action – Partner with Taj Pharma

For distributors, importers, and PCD pharma partners, Taj Pharma is the leading source for Etodolac Extended-release Tablets 400mg.

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Phone: +91 84484 44095 (Gen. Enq. 01)

Partner with Taj Pharma today for WHO-GMP-certified formulations, global compliance, and competitive pricing.

Top 20 FAQs on Etodolac Extended-release Tablets 400mg

1. What is Etodolac ER 400mg used for?
   It relieves pain and inflammation in arthritis and musculoskeletal disorders.

2. How does it work?
   By blocking chemical messengers that cause pain and inflammation.

3. Who manufactures it?
   Taj Pharma, a WHO-GMP-certified manufacturer in India.

4. Can it be exported globally?
   Yes, Taj Pharma provides full regulatory documentation for international buyers.

5. How should it be taken?
   With food or milk to reduce stomach upset, as a whole tablet.

6. Is private labeling available?
   Yes, OEM and custom branding options are offered.

7. Common side effects?
   Nausea, dizziness, diarrhea, heartburn, and abdominal discomfort.

8. Is it safe for long-term use?
   Safe under medical supervision with regular monitoring.

9. Shelf life?
   24–36 months.

10. Storage conditions?
    Store below 25°C, away from moisture and sunlight.

11. Dosage form?
    Extended-release tablets for convenient dosing.

12. Can it be combined with other medications?
    Only under medical supervision to avoid interactions.

13. Is it WHO-GMP certified?
    Yes, all batches are manufactured under WHO-GMP standards.

14. Target export countries?
    Vietnam, UAE, Kenya, South Africa, and over 40 countries worldwide.

15. Regulatory support for importers?
    Full COPP, CTD dossier, and COA are provided.

16. Recommended dosage?
    As prescribed by a healthcare professional.

17. Can it be taken during pregnancy?
    Consult a doctor; NSAIDs may not be safe during pregnancy.

18. Side effects monitoring?
    Regular check-ups are recommended for gastrointestinal and kidney health.

19. Minimum order quantity for export?
    Flexible MOQs available for bulk buyers.

20. Why choose Taj Pharma?
    WHO-GMP-certified quality, competitive pricing, global supply chain, and reliable regulatory support.