Etodolac Prolonged Release Tablets 300mg

Etodolac Prolonged Release Tablets  300mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• A) Etodolac Prolonged Release Tablets IP 200mg
• B) Etodolac Prolonged Release Tablets IP 300mg
  
• C) Etodolac Prolonged Release Tablets IP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• A) Etodolac Prolonged Release Tablets IP 200mg
  Each film coated prolonged release tablet contains:
  Etodolac IP…………………….200mg
  Excipients………………………………………q.s
  Colour: Titanium Dioxide IP
• B) Etodolac Prolonged Release Tablets IP 300mg
  Each film coated prolonged release tablet contains:
  Etodolac IP……………………………300mg
  Excipients…………………………………………q.s
  Colour: Ponceau 2 R
• C) Etodolac Prolonged Release Tablets IP 600mg
  Each film coated prolonged release tablet contains:
  Etodolac IP…………………………600mg
  Excipients……………………………………………q.s
  Colour: Lake of indigo carmine

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 & 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 and moisture.
• Dosage: As directed by the Physician

1. Introduction: Etodolac Prolonged Release Tablets 300mg – Uses, Benefits, and Global Demand

Etodolac Prolonged Release Tablets 300mg are a trusted solution for pain relief and inflammation control, primarily prescribed in chronic conditions such as osteoarthritis and rheumatoid arthritis.

As a non-steroidal anti-inflammatory drug (NSAID), Etodolac works by blocking prostaglandin synthesis, the key chemical responsible for inflammation, pain, and fever. Its prolonged-release formulation ensures steady and long-lasting relief, improving patient compliance and comfort.

Taj Pharma, the renowned Etodolac Prolonged Release Tablets 300mg manufacturer in India, ensures high-quality, pure, and effective formulations that meet the most stringent international quality standards.

The global market for NSAIDs like Etodolac 300mg continues to expand due to the rising prevalence of chronic pain and musculoskeletal conditions. Global buyers increasingly prefer Indian WHO-GMP manufacturers like Taj Pharma for their cost-effective, export-compliant, and reliable pharmaceutical solutions.

2.Leading Etodolac Prolonged Release Tablets 300mg Manufacturer in India

Taj Pharma Ltd, based in Vapi, Gujarat, India, is a globally recognized pharmaceutical manufacturer, exporter, and supplier with decades of experience in producing high-quality generic formulations. The company is WHO-GMP and ISO-certified, ensuring international-level standards across all product categories.

Key Highlights:

• WHO-GMP, EU-GMP, and ISO 9001:2015 certified units

• Expertise in regulatory dossier preparation (CTD/eCTD format)

• Products registered and supplied in 80+ countries

• Dedicated export department for seamless global operations

• Affordable pricing and superior quality assurance

Taj Pharma’s Etodolac Prolonged Release Tablets 300mg are developed in compliance with USP/BP/EP pharmacopoeial standards to ensure consistent efficacy, stability, and patient safety.

3. Composition and Pharmacology

Generic Name: Etodolac
Strength: 300mg (Prolonged Release)
Formulation Type: Oral Tablet
Therapeutic Class: Non-steroidal Anti-inflammatory Drug (NSAID)

Mechanism of Action:
Etodolac selectively inhibits the cyclooxygenase-2 (COX-2) enzyme, reducing prostaglandin synthesis responsible for inflammation and pain. The prolonged-release matrix ensures slow drug release, maintaining consistent blood levels and minimizing gastrointestinal irritation.

Indications:

• Rheumatoid Arthritis

• Osteoarthritis

• Musculoskeletal Pain

• Postoperative Pain Management

4. Clinical Benefits of Etodolac Prolonged Release Tablets 300mg

• Effective Pain Management: Provides long-lasting relief in arthritis and joint disorders.

• Prolonged Release: Reduces frequency of dosing, improving adherence.

• Gastroprotective: Lower risk of gastric irritation compared to other NSAIDs.

• Improved Mobility: Reduces stiffness and promotes functional recovery.

Taj Pharma’s Etodolac 300mg Tablets ensure consistent therapeutic outcomes through precision formulation, advanced coating technology, and validated stability profiles.

5. Dosage, Administration, and Safety Information

Recommended Dosage: One tablet daily or as prescribed by a physician.
Route of Administration: Oral
Administration: Take with food or milk to prevent stomach discomfort.
Storage: Store below 30°C, protected from light and moisture.
Shelf Life: 24–36 months (depending on packaging)

Possible Side Effects:

• Nausea or vomiting

• Dizziness

• Abdominal pain or heartburn

• Diarrhea or indigestion

Most side effects are mild and transient. However, prolonged unsupervised use may increase the risk of stomach ulcers or kidney complications—patients should always follow medical guidance.

6. Export Documentation and Regulatory Support for Importers/Distributors

Taj Pharma provides comprehensive regulatory and export documentation required by importers, distributors, and government tenders.

Documents Provided:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• CTD/eCTD Dossier

• Free Sale Certificate

• Stability Data (Zone IVb compliant)

• Manufacturing License

• Product Registration Support

Packaging and Labeling Options:

• Alu-Alu / PVC Blisters / HDPE Bottles

• Custom pack sizes as per client request

• Private labeling and branding support for PCD/Franchise

• Multi-language labeling as per importing country norms

• Barcoded / QR-coded serialization for regulatory traceability

Taj Pharma ensures safe, tamper-proof packaging, maintaining product stability throughout international transit.

7. Global Export Footprint 

As one of the top exporters of Etodolac Prolonged Release Tablets 300mg from India, Taj Pharma supplies high-quality formulations to over 80 countries, including both regulated and semi-regulated markets.

Top Export Destinations:

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Taj Pharma maintains robust international supply chains, ensuring timely deliveries and compliance with each region’s pharmaceutical regulatory framework.

8. Why Taj Pharma is the Most Trusted Etodolac Prolonged Release Tablets 300mg Manufacturer and Exporter

State-of-the-Art Manufacturing:

Taj Pharma’s Vapi facility follows strict cGMP protocols, featuring modern HVAC systems, validated equipment, and automated production lines. Each batch undergoes in-process quality control, microbial testing, and assay validation before release.

Uncompromised Quality:

• 100% compliance with WHO-GMP & Schedule M

• Double-blind testing for purity and potency

• Zero contamination policy across all units

Affordable Pricing & Scalability:

Taj Pharma’s competitive pricing models make it an ideal partner for both large-scale distributors and small importers seeking reliable supply with margin-friendly rates.

Regulatory Excellence:

Backed by a dedicated RA team, Taj Pharma provides complete dossier preparation, validation reports, and COPP documentation, ensuring smooth registration and approval in all target markets.

9. Technical Product Specification Table

10. Certifications and Quality Assurance

Taj Pharma’s reputation is built on regulatory compliance and manufacturing excellence.

Certifications Include:

• WHO-GMP

• EU-GMP

• ISO 9001:2015

• COPP (WHO Format)

• FDA India (CDSCO Approved)

• Dossier in CTD/eCTD Format

Each formulation undergoes stability, dissolution, and impurity profiling, ensuring consistent bioequivalence across all batches.

11. Partner with Taj Pharma for Global Supply

If you’re looking for a trusted Etodolac Prolonged Release Tablets 300mg Manufacturer, Supplier, or Exporter in India, Taj Pharma is your go-to partner for quality, compliance, and reliability.

📞 Contact Taj Pharma Ltd
Head Office: Plot No. 512, GIDC Industrial Estate, Vapi, Gujarat, India
Email: info@tajpharma.com
Export Enquiries: export@tajpharma.com
Website: www.tajpharma.com

Taj Pharma welcomes importers, distributors, and PCD franchise partners for long-term business collaborations and registration support worldwide.

12. Top 20 FAQs  

1. What is Etodolac Prolonged Release Tablets 300mg used for?
It is used for pain and inflammation in arthritis and musculoskeletal conditions.

2. Who manufactures Etodolac PR Tablets 300mg in India?
Taj Pharma Ltd, Vapi, Gujarat, is the top WHO-GMP-certified manufacturer and exporter.

3. What is the mechanism of action?
Etodolac inhibits prostaglandin synthesis, reducing inflammation and pain.

4. Can it be used for long-term therapy?
Yes, under a doctor’s supervision for chronic arthritis or joint conditions.

5. What are the common side effects?
Nausea, abdominal pain, dizziness, diarrhea, and heartburn.

6. Is it safe for pregnant women?
Consult a physician before use during pregnancy or lactation.

7. What is the shelf life?
24 to 36 months, depending on packaging.

8. Does Taj Pharma provide export documentation?
Yes — including WHO-GMP, COPP, CTD Dossier, and stability data.

9. Is private labeling available?
Yes, Taj Pharma supports custom branding and labeling services.

10. What markets does Taj Pharma export to?
Asia, Africa, the Middle East, and Latin America.

11. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO, COPP, and CDSCO approval.

12. What is the recommended dose?
Usually one 300mg tablet once daily after food.

13. Can I import Taj Pharma products for resale?
Yes, Taj Pharma exports globally and supports registrations.

14. How does Taj Pharma ensure quality?
Through validated GMP systems and 100% batch testing.

15. Are Etodolac Tablets 300mg affordable for bulk buyers?
Yes, Taj Pharma offers highly competitive export pricing.

16. Does Taj Pharma offer samples for registration?
Yes, upon request for regulatory submissions.

17. Are CTD dossiers available?
Yes, complete regulatory dossiers are provided.

18. Can Etodolac cause stomach irritation?
Mild gastric discomfort may occur; take with food to avoid it.

19. Is it suitable for elderly patients?
Yes, with medical monitoring for kidney and stomach health.

20. Why choose Taj Pharma?
Because of its unmatched quality, compliance, and global trust.

Taj Pharma is a globally trusted name in the production and export of Etodolac Prolonged Release Tablets 300mg. With state-of-the-art facilities, regulatory expertise, and a commitment to quality, the company continues to lead as the 1 WHO-GMP-certified manufacturer and exporter in India. For importers, PCD partners, and distributors, Taj Pharma ensures affordable pricing, consistent supply, and complete documentation — making it the preferred global source for Etodolac Prolonged Release Tablets 300mg.