GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Acitretin Capsule USP 17.5mg
C) Acitretin Capsule USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard gelatin capsule contains:
Acitretin IP……………...........................25mg
Excipients………………………………………..q.s.
B) Acitretin Capsule IP 17.5mg
Each Hard gelatin capsule contains:
Acitretin IP……………............................17.5mg
Excipients………………………………………..q.s.
C) Acitretin Capsule IP 10mg
Each Hard gelatin capsule contains:
Acitretin IP……………............................10mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Dosage: As directed by the Physician
Attach dispensing label here
Acitretin Capsule 25mg Technical Specification:
| Product Name: | Acitretin Capsule USP |
| Brand Name: | Generic |
| Strength: | 25mg, 17.5mg, 10mg |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Dermatological |
| Indication: | Acitretin is a retinoid, which is a form of vitamin A. Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication. Acitretin may also be used for purposes not listed in this medication guide |
| Storage: | Store at 20° to 25°C (68° to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Acitretin Capsule USP 25mg
- Acitretin Capsule USP 17.5mg
- Acitretin Capsule USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Acitretin Capsule IP 25mg
Each Hard gelatin capsule contains:
Acitretin IP……………………………………25mg
Excipients………………………………………..q.s. - Acitretin Capsule IP 17.5mg
Each Hard gelatin capsule contains:
Acitretin IP…………………………………….17.5mg
Excipients………………………………………..q.s - Acitretin Capsule IP 10mg
Each Hard gelatin capsule contains:
Acitretin IP…………………………………….10mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
- Acitretin is a retinoid, which is a form of vitamin A. Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication. Acitretin may also be used for purposes not listed in this medication guide
CAUTION & WARNING:
- CAUTION: Dispense in well-closed containers.
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).
- Dosage: As directed by the Physician
Attach dispensing label here
Introduction to Acitretin Capsule 25mg
What It Is
Acitretin is a second-generation retinoid, which works by normalizing the growth cycle of skin cells and reducing inflammation. The 25mg strength is commonly prescribed for adults with moderate to severe plaque psoriasis or other keratinization disorders.
Uses and Benefits
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Treats severe psoriasis and skin keratinization disorders
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Reduces scaling, redness, and thickness of psoriatic plaques
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Used when other therapies such as methotrexate or phototherapy fail
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Helps prevent disease relapse with proper long-term management
Common Side Effects
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Dry lips and mouth
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Skin peeling and irritation
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Joint pain
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Itching
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Runny nose or nosebleeds
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Hair loss
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Elevated blood fats
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Dizziness or sleepiness
Global Demand
With psoriasis affecting 125 million people worldwide, the demand for high-quality, reliable Acitretin Capsule 25mg has increased substantially. Markets in Europe, North America, and Asia require WHO-GMP certified products, making Taj Pharma a preferred partner for international buyers.
In-Depth Details for Importers, Exporters & Buyers
Taj Pharma provides comprehensive export support, including regulatory documentation, custom packaging, and supply chain management for global buyers.
Regulatory Documentation Provided
International buyers benefit from complete regulatory support:
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WHO-GMP Certification
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EU-GMP Compliance
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ISO 9001:2015 Certification
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Certificate of Pharmaceutical Product (COPP)
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Free Sale Certificate (FSC)
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Batch-specific Certificate of Analysis (COA)
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CTD Dossier for drug registration
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MSDS and Stability Reports
This ensures seamless approval in target markets.
Custom Packaging & Labeling
Taj Pharma provides:
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Alu-Alu blister packs for enhanced protection
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HDPE bottles for bulk orders
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Multi-language labeling for international compliance
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Tamper-evident packaging
-
Private labeling options for distributors and PCD Pharma partners
Shelf-Life, Storage & Dosage Form
| Parameter | Specification |
|---|---|
| Dosage Form | Capsule |
| Strength | 25mg |
| Shelf-life | 24–36 months |
| Storage | Store below 25°C, away from moisture and sunlight |
| Packaging | Alu-Alu blister, HDPE bottles |
| Administration | Oral, with food, as prescribed by doctor |
| Prescription Status | Prescription-only in most countries |
Export Certifications Offered
Taj Pharma ensures compliance with global standards:
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WHO-GMP certified manufacturing
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EU-GMP compliant facilities
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ISO-certified quality management
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COPP & FSC for international exports
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CTD/ACTD dossier for regulatory approval
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Batch-specific COA and stability reports
Target Countries & Export Markets
Taj Pharma exports Acitretin Capsule 25mg to over 40 countries globally, 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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Nigeria
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Kenya
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South Africa
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Ghana
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Russia
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Ukraine
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Kazakhstan
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Vietnam
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Philippines
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Nepal
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Sri Lanka
-
Australia
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Brazil
-
Chile
Why Taj Pharma is the Most Trusted Manufacturer & Exporter
1. State-of-the-Art Manufacturing
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Modern WHO-GMP certified production units
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Advanced capsule filling and packaging technology
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Automated quality control
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Sophisticated analytical labs for raw materials and finished product testing
2. Affordable Pricing & Quality Assurance
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Competitive pricing for bulk and PCD orders
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Strict quality control to ensure product consistency
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Regulatory compliance across international markets
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Private labeling and franchise options
3. Global Supply Chain & Support
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Temperature-controlled logistics for export
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Fast order processing and shipment
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Complete documentation for customs and regulatory approval
-
Flexible solutions for distributors, wholesalers, and PCD partners
4. Top 20 Export Countries
India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile
Technical Product Specification Table
| Attribute | Specification |
|---|---|
| Brand Name | Acitretin Capsule 25mg |
| Strength | 25mg |
| Manufacturer | Taj Pharma, India |
| Dosage Form | Capsule |
| Therapeutic Class | Retinoid / Anti-psoriatic |
| Indication | Severe psoriasis, keratinization disorders |
| Packaging | Alu-Alu blister, HDPE bottle |
| Shelf-life | 24–36 months |
| Certifications | WHO-GMP, ISO, GLP |
| MOQ | Flexible per buyer requirement |
| Export Support | CTD/ACTD dossier, FSC, COPP, COA |
Call to Action
For reliable Acitretin Capsule 25mg Manufacturer & Supplier in India, Taj Pharma is the preferred choice.
We offer:
-
Bulk export orders
-
PCD Pharma franchise opportunities
-
Private label production
-
Full regulatory documentation support
-
Global supply chain assistance
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📍 Location: Vapi, Gujarat, India
Top 20 FAQs
1. What is Acitretin 25mg used for?
Treatment of severe psoriasis and keratinization disorders.
2. Who is the leading manufacturer in India?
Taj Pharma, WHO-GMP certified.
3. How does it work?
Normalizes skin cell growth and reduces inflammation.
4. Is it WHO-GMP approved?
Yes, along with EU-GMP and ISO certifications.
5. Packaging options?
Alu-Alu blister packs and HDPE bottles.
6. Shelf life?
24–36 months.
7. Regulatory dossiers provided?
CTD/ACTD dossiers for international registration.
8. Private labeling available?
Yes, for distributors and PCD partners.
9. Common side effects?
Dry lips, skin peeling, hair loss, joint pain, elevated blood fats.
10. Safe for pregnant women?
No, strictly contraindicated.
11. Export markets?
Over 40 countries in Europe, Middle East, Africa, and Asia.
12. COA availability?
Yes, batch-specific Certificate of Analysis provided.
13. Recommended dosage?
As prescribed by a doctor, taken with food.
14. Suitable for government tenders?
Yes, supplied for international tenders.
15. Moisture-resistant packaging?
Yes, Alu-Alu and HDPE packaging.
16. Monopoly rights for distributors?
Yes, under PCD Pharma franchise.
17. Stability studies?
Real-time and accelerated studies available.
18. Shipping timelines?
7–15 business days internationally.
19. Sample availability?
Yes, for registered buyers.
20. Why choose Taj Pharma?
High-quality, compliant manufacturing, competitive pricing, reliable global supply.






