GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Stiripentol Capsule 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin Capsule contains:
Stiripentol 250mg
Excipients q.s
Approved colours used in capsule shells.
B) Stiripentol Capsule 500mg
Each Capsule contains:
Stiripentol 500mg
Excipients q.s
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE WITH A GLASS OF WATER DURING A MEAL. DO NOT OPEN, BREAK OR CHEW CAPSULE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Store in original package to protect from light.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Stiripentol Capsule 250mg Technical Specification:
| Product Name: | Stiripentol Capsule |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg |
| 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: | Central Nervous System, anticonvulsant |
| Indication: | Stiripentol is a prescription medicine used to treat the symptoms of Seizures. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Stiripentol Capsule 250mg
B) Stiripentol Capsule 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Stiripentol Capsule 250mg
Each hard gelatin Capsule contains:
Stiripentol 250mg
Excipients q.s
Approved colours used in capsule shells.
B) Stiripentol Capsule 500mg
Each Capsule contains:
Stiripentol 500mg
Excipients q.s
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Stiripentol is a prescription medicine used to treat the symptoms of Seizures. Stiripentol may be used alone or with other medications. Diacomit belongs to a class of drugs called Anticonvulsants.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE WITH A GLASS OF WATER DURING A MEAL. DO NOT OPEN, BREAK OR CHEW CAPSULE.
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].
Store in original package to protect from light.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Introduction to Stiripentol Capsule 250mg
Stiripentol Capsule 250mg is a prescription anti-epileptic medication primarily used to control seizures in patients with Dravet syndrome, a rare and severe form of epilepsy beginning in early childhood. It is recommended for adults and children aged six months and older, weighing at least 7 kg (15 pounds). Stiripentol works as an adjunctive therapy to suppress abnormal electrical activity in the brain and is typically administered alongside other anti-epileptic drugs such as clobazam and valproate.
Globally, the demand for Stiripentol Capsule 250mg is growing due to increasing awareness of rare epileptic disorders, better diagnostic tools, and rising preference for advanced anticonvulsant therapies. Dravet syndrome requires specialized treatment protocols, and high-quality, standardized formulations are in strong demand among neurologists, hospitals, and pharmaceutical distributors worldwide.
India has become a hub for cost-effective, high-quality pharmaceutical production. Taj Pharma is recognized as a top Stiripentol Capsule 250mg Manufacturer in India, delivering trusted and regulatory-compliant formulations for international markets.
About Stiripentol Capsule 250mg – Uses and Benefits
Stiripentol Capsule 250mg is used for:
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Adjunctive therapy for seizures associated with Dravet syndrome
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Seizure control in adults and children
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Management of symptoms such as somnolence, decreased appetite, weight loss, agitation, ataxia, and low muscle tone
Taj Pharma ensures high-quality, pure stiripentol capsules manufactured under strict WHO-GMP guidelines. Patients can take this medicine with or without food, ideally at the same time daily. Dosages are individualized by physicians and may be gradually increased based on patient response. Continuous therapy is essential to prevent seizure recurrence, and abrupt discontinuation can worsen the condition.
Additionally, stiripentol may be used in combination with other medical treatments, including dopamine agonists, for related conditions such as prolactin excess, menstrual irregularities, and pituitary tumors, ensuring broad therapeutic utility.
Trusted Stiripentol Capsule 250mg Manufacturer in India
Taj Pharma Ltd, India, is a reputed Manufacturer, Exporter, and Supplier of Stiripentol Capsule 250mg based in Vapi, Gujarat. Known for its commitment to quality, Taj Pharma guarantees consistent purity, efficacy, and international compliance in every batch.
As a top Stiripentol Capsule 250mg Manufacturer Supplier in India, Taj Pharma serves:
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International importers and distributors
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Hospitals and healthcare institutions
-
PAN India PCD Pharma Franchise partners
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Government tenders and institutional clients
With Taj Pharma, global buyers gain a reliable partner for high-quality stiripentol capsules and consistent supply chains.
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma provides comprehensive regulatory support, ensuring smooth international trade:
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WHO-GMP Certificate
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Certificate of Pharmaceutical Product (COPP)
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Certificate of Analysis (COA)
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Stability study reports
-
Product specifications and testing methods
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CTD / ACTD Dossier
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Drug Master File (DMF) support
This documentation streamlines product registrations and approvals in global markets.
Custom Packaging & Labeling
To meet diverse international standards, Taj Pharma offers:
-
Country-specific packaging and labeling
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Multilingual artwork
-
Private labeling for distributors
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Blisters, alu-alu, alu-PVC, bottles, and bulk packaging options
Shelf-Life, Storage & Dosage Form
-
Dosage Form: Hard gelatin capsule
-
Strength: 250mg
-
Shelf Life: 24–36 months
-
Storage: Store below 25°C, protect from moisture and direct sunlight
Export Certifications
Taj Pharma, a WHO-GMP Manufacturer in India, provides:
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WHO-GMP compliance for all manufacturing processes
-
ISO-certified quality systems
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EU-GMP support through dossiers
-
Regulatory-ready export products
Target Countries & Export Markets
Stiripentol Capsule 250mg export from India by Taj Pharma covers:
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Asia (Philippines, Vietnam, Thailand, Myanmar, Sri Lanka)
-
Africa (Kenya, Nigeria, Ghana, Ethiopia, South Africa)
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Middle East (UAE, Saudi Arabia, Iraq, Yemen)
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CIS countries (Uzbekistan, Kazakhstan)
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Latin America (Peru, Bolivia, Guatemala, Dominican Republic)
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
State-of-the-Art Manufacturing
Taj Pharma’s Vapi facility features:
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Automated and validated production lines
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Advanced quality control laboratories
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Strict in-process and final product testing
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Compliance with international pharmacopoeial standards
Affordable Pricing & Quality Assurance
As a direct Stiripentol Capsule 250mg Manufacturer in India, Taj Pharma provides:
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Competitive pricing without compromising quality
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High-purity APIs and stable formulations
-
Batch-to-batch consistency
Global Presence & Supply Chain Support
Taj Pharma ensures:
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Timely shipment and delivery
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Strong logistics support for global markets
-
Flexible MOQs for distributors
-
End-to-end export documentation support
Top 20 Countries Exporting Stiripentol Capsule 250mg
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
| Parameter | Specification |
|---|---|
| Product Name | Stiripentol Capsule 250mg |
| Active Ingredient | Stiripentol |
| Strength | 250mg |
| Dosage Form | Hard Gelatin Capsule |
| Therapeutic Class | Anti-Epileptic / Adjunctive Therapy |
| Packaging | Blister / Bottle / Bulk |
| Shelf Life | 24–36 Months |
| Storage | Below 25°C |
| Regulatory Status | WHO-GMP Certified |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat, India |
PAN India Presence & PCD Pharma Franchise Opportunities
Taj Pharma is a Stiripentol Capsule 250mg PAN India Manufacturer, offering:
-
Monopoly-based PCD Pharma Franchise
-
Comprehensive marketing and promotional support
-
Competitive pricing for Mumbai, Maharashtra, and PAN India
-
Reliable supply and brand recognition
Call to Action
For high-quality, export-ready Stiripentol Capsule 250mg Manufacturer & Supplier in India, Taj Pharma is the ideal partner. With global regulatory support, consistent supply, and competitive pricing, distributors, importers, and PCD franchise partners can confidently expand their anti-epileptic portfolios.
👉 Contact Taj Pharma today for quotations, product samples, regulatory dossiers, or franchise inquiries.
Top 20 FAQs
Q1. What is Stiripentol Capsule 250mg used for?
Adjunctive therapy for seizures in Dravet syndrome and related neurological conditions.
Q2. Is Taj Pharma a WHO-GMP manufacturer?
Yes, Taj Pharma is WHO-GMP certified.
Q3. Can it be used with other anti-epileptic drugs?
Yes, often used with clobazam and valproate.
Q4. Does Taj Pharma export globally?
Yes, to regulated and semi-regulated markets worldwide.
Q5. What export documents are provided?
COA, COPP, WHO-GMP, CTD dossier, and stability data.
Q6. Is private labeling available?
Yes, private and contract manufacturing options are available.
Q7. What is the shelf life?
24–36 months.
Q8. Where is Taj Pharma located?
Vapi, Gujarat, India.
Q9. Can I request samples?
Yes, samples are provided upon request.
Q10. Is it safe for long-term use?
Yes, under medical supervision.
Q11. Can sudden discontinuation worsen seizures?
Yes, stopping abruptly can worsen seizure control.
Q12. Is bulk supply available?
Yes, bulk and institutional supplies are provided.
Q13. Does Taj Pharma offer PCD franchise?
Yes, PAN India PCD Pharma Franchise opportunities exist.
Q14. What packaging formats are offered?
Blisters, bottles, and bulk packaging.
Q15. Is it export-ready?
Yes, compliant with international quality standards.
Q16. Does Taj Pharma ensure batch consistency?
Yes, strict QA/QC measures are followed.
Q17. Is it prescription-only?
Yes, it requires medical supervision.
Q18. Can dosage be adjusted?
Dosage is determined by the physician.
Q19. Does Taj Pharma provide regulatory support?
Yes, dossiers and registration support are available.
Q20. How can I contact Taj Pharma?
Through official inquiry channels for quotes, samples, and partnerships.






