GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Sustained Release tablet contains:
Ibuprofen IP….800mg
Excipients………q.s
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma, Ibuprofen should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, rhinitis or urticarial.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Protect from Light and moisture.
Dosage: As directed by the Physician.
Ibuprofen Sustained Release Tablets 800mg Technical Specification:
| Product Name: | Ibuprofen Sustained Release Tablets |
| Brand Name: | Generic |
| Strength: | (800mg) |
| Dosage Form: | Tablets(Sustained-Release) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Analgesic and Anti-inflammatory |
| Indication: | Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Ibuprofen Sustained Release Tablets 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Ibuprofen Sustained Release Tablets 800mg
Each Sustained Release tablet contains:
Ibuprofen IP….800mg
Excipients………q.s
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma, Ibuprofen should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, rhinitis or urticarial.
WARNING: 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.
Introduction to Ibuprofen Sustained Release Tablets 800mg
Ibuprofen Sustained Release Tablets 800mg are a nonsteroidal anti-inflammatory drug (NSAID) widely used for the relief of mild to moderate pain, inflammation, and fever. They are particularly effective for:
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Headaches and migraine management
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Dental pain and post-procedural discomfort
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Muscle aches and back pain
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Arthritis and joint pain
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Primary dysmenorrhea (menstrual cramps)
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Fever reduction due to cold, flu, or viral infections
As a leading Ibuprofen Sustained Release Tablets 800mg manufacturer in India, Taj Pharma ensures high-quality, pure, and effective formulations for both domestic and international markets.
Global Demand:
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Increasing prevalence of musculoskeletal disorders
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Rising geriatric population experiencing joint pain and arthritis
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Growing demand for over-the-counter pain relief medications
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Expanding pharmaceutical exports from India to global markets
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma supplies comprehensive regulatory documents to ensure smooth global import/export processes:
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WHO-GMP certification
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EU-GMP approval
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Certificate of Pharmaceutical Product (COPP)
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CTD Dossier for regulatory filings
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Free Sale Certificate (FSC)
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Batch-wise Certificate of Analysis (CoA)
These documents guarantee compliance with international standards for global buyers and distributors.
Custom Packaging & Labeling
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Multiple packaging options: blister strips, bottles, cartons
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Multilingual labeling for international markets
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Private-label packaging for distributors and PCD Pharma franchise partners
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Tamper-proof, child-resistant, and eco-friendly packaging
Shelf-Life, Storage & Dosage Form
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Dosage Form: Oral sustained-release tablets, 800mg
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Shelf-Life: 24–36 months
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Storage Conditions: Store in a cool, dry place, protected from light
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Dosage Instructions: Follow physician recommendations; avoid exceeding prescribed dose
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Important Note: Use with caution in patients with stomach ulcers or kidney disease
Export Certifications
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WHO-GMP & EU-GMP certified
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ISO 9001 & ISO 14001 certified
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COPP & Free Sale Certificate for global export
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CTD dossier support for international registration
Target Countries & Export Markets
Taj Pharma exports Ibuprofen Sustained Release Tablets 800mg to over 70 countries worldwide, including:
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Asia: Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines
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Africa: Nigeria, Kenya, Ghana, South Africa, Ethiopia
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Middle East: UAE, Saudi Arabia, Oman, Qatar, Bahrain
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Europe & CIS: Ukraine, Kazakhstan, Belarus, Georgia
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Latin America: Chile, Peru, Bolivia, Guatemala
Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter
1. State-of-the-Art Manufacturing
Taj Pharma’s facilities in Vapi, Gujarat are equipped with:
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Modern automated production lines
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Cleanroom environments for contamination-free manufacturing
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Advanced quality control laboratories for strict testing of purity, efficacy, and stability
2. Affordable Pricing & Quality Assurance
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Competitive pricing with high-quality assurance
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Rigorous batch testing ensures consistent therapeutic effects
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Commitment to WHO-GMP and EU-GMP standards
3. Global Presence & Supply Chain Support
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Strong export network ensures timely delivery and bulk supply
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Custom solutions for distributors and PCD Pharma franchise partners
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Reliable support for international regulatory compliance
4. Top 20 Countries Exporting
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Nigeria
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Kenya
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Ghana
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Ethiopia
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Bangladesh
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Sri Lanka
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Nepal
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Vietnam
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Philippines
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UAE
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Saudi Arabia
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Oman
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Qatar
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Ukraine
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Kazakhstan
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Belarus
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Georgia
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Peru
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Chile
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Bolivia
Technical Product Specification Table
| Parameter | Details |
|---|---|
| Product Name | Ibuprofen Sustained Release Tablets 800mg |
| Active Ingredient | Ibuprofen 800mg |
| Therapeutic Category | Pain Relief / Anti-inflammatory |
| Indications | Mild-to-moderate pain, primary dysmenorrhea, fever, arthritis |
| Dosage Form | Oral sustained-release tablets |
| Strength | 800mg |
| Packaging Options | Blister strips, bottles, cartons |
| Shelf Life | 24–36 months |
| Storage Conditions | Cool, dry place, away from light |
| Certifications | WHO-GMP, EU-GMP, COPP, ISO, CTD Dossier |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
Are you looking for a trusted WHO-GMP certified Ibuprofen Sustained Release Tablets 800mg manufacturer in India? Taj Pharma provides:
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Bulk manufacturing & global export solutions
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Private-label supply & PCD Pharma Franchise opportunities
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Custom packaging & labeling for international markets
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Affordable pricing with consistent high-quality assurance
📩 Contact Taj Pharma Today:
Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
Top 20 FAQs
Q1. What is Ibuprofen 800mg used for?
A: Relief from mild-to-moderate pain, fever, inflammation, and menstrual cramps.
Q2. How should it be taken?
A: Orally, following the doctor’s prescription.
Q3. Can it be used for children?
A: Clinical trials for children are not established; consult a pediatrician.
Q4. Common side effects?
A: Nausea, dizziness, stomach pain, headache, mild rash.
Q5. Serious side effects?
A: Severe stomach pain, vomiting blood, black/tarry stools, swelling, unusual weight gain, yellowing of skin.
Q6. Can it be used during pregnancy?
A: Consult your physician; NSAIDs are generally avoided in late pregnancy.
Q7. Can it be used while breastfeeding?
A: Limited amounts enter breast milk; consult a doctor before use.
Q8. Can it affect blood pressure?
A: NSAIDs may slightly increase blood pressure; monitor regularly.
Q9. Storage conditions?
A: Store in a cool, dry place, away from direct sunlight.
Q10. Shelf-life of Ibuprofen 800mg tablets?
A: 24–36 months.
Q11. Can it be combined with other medications?
A: Avoid mixing with other NSAIDs; consult a doctor for drug interactions.
Q12. Are export dossiers provided?
A: Yes, complete CTD dossiers and regulatory support are available.
Q13. Is private-labeling available?
A: Yes, for distributors and PCD Pharma franchise partners.
Q14. How quickly does it relieve pain?
A: Effects may be felt within 30–60 minutes; sustained release lasts longer.
Q15. Can it cause gastrointestinal bleeding?
A: Rare but possible; use caution in patients with ulcers or GI issues.
Q16. Can it be taken with food?
A: Yes, taking with food reduces stomach irritation.
Q17. Is it WHO-GMP certified?
A: Yes, Taj Pharma’s facilities comply with WHO-GMP standards.
Q18. Is international shipping available?
A: Yes, Taj Pharma exports to 70+ countries.
Q19. Can it be used for arthritis?
A: Yes, it helps reduce inflammation, pain, and stiffness.
Q20. Why choose Taj Pharma for Ibuprofen 800mg?
A: WHO-GMP compliance, high-quality assurance, affordable pricing, reliable global supply chain, and private-label options.
Taj Pharma stands as the leading Ibuprofen Sustained Release Tablets 800mg manufacturer in India, providing WHO-GMP quality, international certifications, competitive pricing, and reliable export services. Global buyers and distributors can confidently partner with Taj Pharma for safe, effective, and compliant pain relief solutions.






