GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Etodolac Tablets 400mg
C) Etodolac Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Etodolac ……………..300mg
Excipients…………………..q.s
Colour: Lake of Erythrosine
B) Etodolac Tablets 400mg
Each film coated tablet contains:
Etodolac ……………….400mg
Excipients……………………..q.s
Colour: Ponceau 4 R
C) Etodolac Tablets 500mg
Each film coated tablet contains:
Etodolac ……………..500mg
Excipients…………………..q.s
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE : To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dispense in tight and light resistant container.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Etodolac Tablets 400mg Technical Specification:
| Product Name: | Etodolac Tablets IP |
| Brand Name: | Generic |
| Strength: | 300mg, 400mg, 500mg |
| 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 Tablets 300mg
B) Etodolac Tablets 400mg
C) Etodolac Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Etodolac Tablets 300mg
Each film coated tablet contains:
Etodolac ……………..300mg
Excipients…………………..q.s
Colour: Lake of Erythrosine
B) Etodolac Tablets 400mg
Each film coated tablet contains:
Etodolac ……………….400mg
Excipients……………………..q.s
Colour: Ponceau 4 R
C) Etodolac Tablets 500mg
Each film coated tablet contains:
Etodolac ……………..500mg
Excipients…………………..q.s
Colour: Quinoline yellow WS
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
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 Tablets 400mg
Etodolac Tablets 400mg is a non-steroidal anti-inflammatory drug (NSAID) widely prescribed for the treatment of pain and inflammation associated with conditions like rheumatoid arthritis and osteoarthritis. It effectively alleviates pain, swelling, and stiffness, enabling patients to improve mobility and quality of life.
Etodolac works by inhibiting cyclooxygenase (COX) enzymes, which are responsible for producing prostaglandins – chemicals that trigger pain and inflammation. Its effectiveness and safety profile have made it a globally demanded medication in both hospital and retail pharmacy markets.
Taj Pharma, located in Vapi, Gujarat, India, is a reputed Etodolac Tablets 400mg manufacturer, supplier, and exporter, offering WHO-GMP certified products for domestic and international markets.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures smooth and compliant international trade by providing comprehensive documentation for Etodolac Tablets 400mg:
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Certificate of Analysis (CoA)
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Certificate of Pharmaceutical Product (CPP/COPP)
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Drug Master File (DMF)
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WHO-GMP Certification
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EU-GMP Certification
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CTD Dossier for regulatory submissions
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ISO 9001 & 14001 Certifications
These documents guarantee product authenticity, compliance with international standards, and smooth import registration for global distributors.
Custom Packaging & Labeling
To meet international standards and buyer requirements, Taj Pharma offers:
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Alu-Alu blister packs and strip packs
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HDPE bottles
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Customized labeling with distributor branding
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Tamper-evident, export-ready packaging
Custom packaging ensures product integrity during transportation and compliance with local regulatory laws in target markets.
Shelf-Life, Storage, and Dosage Form
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Dosage Form: Tablets, 400mg
-
Shelf-Life: Minimum 24 months from manufacture date
-
Storage Conditions: Store below 30°C in a dry, dark place; protect from moisture and sunlight
Etodolac Tablets 400mg are formulated to maintain stability, efficacy, and safety throughout storage and transit.
Export Certifications and Compliance
As a WHO-GMP manufacturer in India, Taj Pharma ensures global compliance:
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WHO-GMP Certification
-
EU-GMP Certification
-
Certificate of Pharmaceutical Product (CPP/COPP)
-
CTD Dossier for regulatory submission
These certifications reflect Taj Pharma’s commitment to international quality standards, making it a reliable partner for worldwide buyers.
Target Countries & Export Markets
Taj Pharma exports Etodolac Tablets 400mg to over 50 countries, including:
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USA
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UK
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Germany
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France
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UAE
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Saudi Arabia
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South Africa
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Kenya
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Nigeria
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Bangladesh
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Sri Lanka
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Philippines
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Vietnam
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Australia
-
Canada
Timely delivery, secure packaging, and complete compliance with regulatory requirements make Taj Pharma a preferred choice for international distributors.
Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter
State-of-the-Art Manufacturing
Taj Pharma’s Vapi, Gujarat facility features advanced manufacturing technology:
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ISO-certified production units
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Automated cleanrooms with HEPA filtration
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Modern quality control laboratories
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Strict adherence to WHO-GMP and EU-GMP standards
Every batch of Etodolac Tablets 400mg undergoes rigorous quality control to ensure safety, efficacy, and consistency.
Affordable Pricing & Quality Assurance
Taj Pharma provides a perfect combination of superior quality and cost-effective pricing:
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Transparent pricing for domestic and international orders
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Competitive rates for bulk purchases
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Third-party lab validations for extra assurance
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Flexible shipping and payment options
Global Presence & Supply Chain Support
Taj Pharma has an established global distribution network, offering:
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Seamless international logistics
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Complete documentation for customs and regulatory approvals
-
Personalized buyer support for hassle-free transactions
Top 20 Countries Exporting
India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA
Technical Product Specification Table
| Product Name | Etodolac Tablets 400mg |
|---|---|
| Dosage Form | Tablet |
| Strength | 400mg |
| Packing | Alu-Alu blister packs, HDPE bottles, strip packs |
| Shelf Life | 24 months |
| Storage | Store below 30°C, away from moisture and sunlight |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat, India |
| Regulatory Compliance | WHO-GMP, EU-GMP, COPP, CTD Dossier |
| Uses | Pain and inflammation relief in osteoarthritis and rheumatoid arthritis |
| Side Effects | Vomiting, nausea, dizziness, diarrhea, heartburn, abdominal pain, flatulence, dyspepsia |
Call to Action for Buyers and Distributors
International distributors, PCD Pharma franchise owners, and pharmaceutical importers seeking a reliable Etodolac Tablets 400mg manufacturer in India can partner with Taj Pharma for:
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WHO-GMP and EU-GMP certified products
-
Competitive pricing and bulk order options
-
Flexible packaging and labeling
-
Complete documentation for seamless global trade
Contact Taj Pharma today to source high-demand Etodolac Tablets 400mg for global markets.
Top 20 FAQs About Etodolac Tablets 400mg
-
What is Etodolac Tablets 400mg used for?
To relieve pain and inflammation in conditions like osteoarthritis and rheumatoid arthritis. -
How does Etodolac work?
By blocking COX enzymes that produce prostaglandins, reducing pain, swelling, and inflammation. -
Can it be taken with food?
Yes, taking it with food or milk helps prevent stomach upset. -
What are the common side effects?
Vomiting, nausea, dizziness, diarrhea, heartburn, abdominal pain, flatulence, and dyspepsia. -
Is Taj Pharma a WHO-GMP manufacturer?
Yes, Taj Pharma holds WHO-GMP and EU-GMP certifications. -
Can I get customized packaging for exports?
Yes, options include Alu-Alu packs, strip packs, and HDPE bottles. -
What is the shelf life?
Minimum 24 months from the date of manufacture. -
Which countries does Taj Pharma export to?
Over 50 countries, including USA, UK, Germany, UAE, and South Africa. -
Does it require a prescription?
Yes, Etodolac should be taken only under medical supervision. -
Is it suitable for long-term use?
Long-term use may cause stomach bleeding or kidney problems; consult a doctor. -
Can it cause dizziness?
Yes, mild dizziness may occur; patients should avoid driving initially. -
Are there storage precautions?
Store below 30°C, protect from moisture and sunlight. -
Can distributors apply for a PCD Pharma franchise?
Yes, Taj Pharma offers franchise opportunities in India and abroad. -
Does Etodolac interact with other medications?
Consult a doctor; it may interact with blood thinners and certain antihypertensives. -
Is it safe for elderly patients?
Caution is advised; monitor kidney function and gastrointestinal health. -
What is the dosage form?
Tablet, 400mg. -
Are bulk order discounts available?
Yes, Taj Pharma offers competitive pricing for large orders. -
How should Etodolac be taken?
As prescribed by a healthcare provider; follow the dosage and duration strictly. -
Can it cause heartburn or stomach pain?
Yes, taking it with food or milk can reduce these risks. -
How can I contact Taj Pharma for orders?
Visit the official website or email info@tajpharma.com for inquiries.






