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
Attach dispensing label as per end country.

Etodolac Extended-release Tablets 600mg Technical Specification:

Product Name: Etodolac Extended-release Tablets USP
Brand Name: Generic
Strength: 400mg, 600mg
Dosage Form: Tablets (Film coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Analgesic and Anti-inflammatory, Antirheumatic, Antiarthritic
Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis including inflammation, swelling, stiffness, and joint pain.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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 600mg

Etodolac Extended-release Tablets 600mg is a non-steroidal anti-inflammatory drug (NSAID) widely used for pain relief and inflammation reduction. It is particularly effective in managing rheumatoid arthritis, osteoarthritis, and musculoskeletal disorders. By blocking chemical messengers responsible for pain and swelling, Etodolac facilitates improved mobility, reduced stiffness, and better quality of life for patients.

The global demand for NSAIDs, including Etodolac, continues to rise due to increasing prevalence of arthritis, chronic pain conditions, and musculoskeletal disorders. Healthcare professionals and pharmaceutical distributors worldwide seek reliable, high-quality suppliers that comply with international standards.

Taj Pharma is recognized as a top Etodolac Extended-release Tablets 600mg manufacturer in India, offering WHO-GMP-certified products designed for global export with consistent quality and safety standards.


Therapeutic Benefits and Uses

Key Benefits

  • Pain and inflammation relief for arthritis patients

  • Improved joint function and reduced stiffness

  • Enhanced patient mobility and daily activity performance

Dosage and Administration

  • Typically taken once or twice daily, depending on physician guidance

  • Should be taken with food or milk to reduce stomach irritation

  • Swallow tablets whole; do not crush or chew

Common Side Effects

While Etodolac ER 600mg is generally well-tolerated, possible side effects include:

  • Nausea and vomiting

  • Dizziness or headache

  • Diarrhea or heartburn

  • Abdominal discomfort, flatulence, and dyspepsia

Taj Pharma ensures precise labeling and clear dosage instructions to minimize risks and maximize treatment efficacy.


Details for Importers and Exporters

Regulatory Documentation Provided

Taj Pharma provides a comprehensive set of documents for global trade compliance:

  • 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 options for distributors and PCD pharma partners

Shelf-life & Storage

  • Shelf Life: 24–36 months

  • Storage: Store below 25°C in a dry, shaded area, away from sunlight

Dosage Form

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

Export Certifications

  • WHO-GMP

  • ISO 9001:2015

  • EU-GMP (for specific markets)

  • COPP and CTD Dossier

Target Export Markets

Taj Pharma exports Etodolac Extended-release Tablets 600mg 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 Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

Taj Pharma’s manufacturing facilities in Vapi, Gujarat are WHO-GMP-certified and equipped with modern pharmaceutical technology. Every batch undergoes rigorous testing for purity, potency, and consistency, ensuring high-quality Etodolac ER tablets.

2. Affordable Pricing and Quality Assurance

By combining cost-efficient production with strict quality control, Taj Pharma delivers competitive pricing without compromising international standards.

3. Global Presence and Supply Chain Support

Taj Pharma offers:

  • Reliable global logistics for timely deliveries

  • Regulatory assistance for import approvals

  • Flexible order quantities for distributors

  • Support for PCD pharma partners to expand local markets

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

Product Name Etodolac Extended-release Tablets 600mg
Composition Etodolac 600mg
Dosage Form Extended-release Tablet
Indications Pain relief and inflammation in rheumatoid arthritis, osteoarthritis, musculoskeletal disorders
Manufacturer Taj Pharmaceuticals Ltd., Vapi, Gujarat, India
Shelf Life 24–36 months
Packaging 10×10 Blister / Alu-Alu Packs
Storage Store below 25°C, dry, away from light
Certifications WHO-GMP, ISO 9001:2015, COPP, CTD Dossier
Market PAN India & International Export Markets
Private Label Available

For distributors, importers, and PCD pharma partners, Taj Pharma is the leading source for Etodolac Extended-release Tablets 600mg.

📧 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 600mg

  1. What is Etodolac ER 600mg used for?
    It relieves pain and inflammation in arthritis and musculoskeletal disorders.

  2. How does it work?
    By blocking chemical messengers that trigger 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; swallow tablets whole.

  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, dry, and away from sunlight.

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

  12. Can it be combined with other medications?
    Only under physician guidance to avoid interactions.

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

  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 regulatory support.