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.

Stiripentol Capsule 500mg 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 500mg

Stiripentol Capsule 500mg is a prescription medication primarily used to control seizures in adults and children aged 6 months and older who weigh at least 7 kg (15 pounds) and are diagnosed with Dravet syndrome, a rare genetic disorder characterized by frequent, severe seizures and possible developmental delays. Stiripentol works as an adjunctive therapy by enhancing GABAergic neurotransmission, thereby reducing abnormal electrical activity in the brain and helping patients achieve better seizure control.

Globally, Dravet syndrome affects thousands of individuals, and effective seizure management remains a critical medical need. Due to the increasing prevalence of neurological disorders and rising awareness of specialized therapies, the demand for Stiripentol Capsule 500mg has grown considerably in European, American, Middle Eastern, and Asian markets. This has made it essential for buyers to partner with a reliable, WHO-GMP certified manufacturer capable of providing high-quality Stiripentol capsules with comprehensive regulatory support.


Taj Pharma – Trusted Stiripentol Capsule 500mg Manufacturer in India

Taj Pharma, the well-known Stiripentol Capsule 500mg Manufacturer in India, assures high-quality, purity, and consistent therapeutic efficacy. Manufactured under stringent cGMP standards, these capsules meet international pharmacopoeial and regulatory requirements.

Taj Pharma Ltd, India is a leading Manufacturer, Exporter, and Supplier of Stiripentol Capsule 500mg from Vapi, Gujarat. It is widely recognized for producing medications to treat Dravet syndrome and other conditions related to hormonal imbalances like excessive prolactin production. Stiripentol can also be integrated into broader neurological and hormonal treatment regimens, providing reliable patient outcomes when used under proper medical supervision.


Therapeutic Uses & Benefits of Stiripentol Capsule 500mg

Taj Pharma Ltd is a top-rated Manufacturer, Exporter, and Supplier of Stiripentol Capsule 500mg in India. Its therapeutic benefits include:

  • Adjunctive treatment for seizures in Dravet syndrome

  • Reducing seizure frequency and severity in patients already on clobazam and/or valproate

  • Improving quality of life for children and adults with epilepsy

  • Supporting long-term seizure management when taken consistently

The medication may cause somnolence, decreased appetite, weight loss, agitation, ataxia, and low muscle tone, which are generally manageable under medical guidance. Patients are advised to take it regularly and not discontinue treatment abruptly, as sudden cessation could exacerbate seizures.


In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma provides complete regulatory support for Stiripentol Capsule 500mg, ensuring smooth import and compliance:

  • Certificate of Pharmaceutical Product (COPP)

  • WHO-GMP Certification

  • EU-GMP compliant manufacturing

  • Certificate of Analysis (COA)

  • Stability and method of analysis (MOA) reports

  • CTD Dossier and export documentation

Custom Packaging & Labeling

  • Blister packs (Alu-Alu or Alu-PVC)

  • HDPE bottles with tamper-proof caps

  • Private labeling and branding options

  • Multilingual patient information leaflets and country-specific labeling

Shelf-Life, Storage & Dosage Form

  • Dosage Form: Hard gelatin capsule

  • Strength: 500mg

  • Shelf Life: 24–36 months

  • Storage: Store below 25°C in a dry place, protected from light

Export Certifications

  • WHO-GMP Certified

  • ISO 9001:2015 Quality Management System

  • GDP-compliant export logistics

Target Countries & Export Markets

Stiripentol Capsule 500mg from Taj Pharma is exported to:

  • Europe (UK, Germany, France, Spain)

  • Middle East (UAE, Saudi Arabia, Qatar)

  • Asia (India, Philippines, Malaysia)

  • Africa (Nigeria, Kenya, South Africa)

  • Latin America (Brazil, Mexico, Chile)


Why Taj Pharma is the Most Trusted Stiripentol Capsule 500mg Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma’s manufacturing facility in Vapi, Gujarat is equipped with:

  • Advanced capsule filling and coating machines

  • In-house quality control laboratories

  • Automated production and packaging lines

  • Compliance with cGMP and international SOPs

Affordable Pricing with Quality Assurance

  • Cost-effective pricing for global buyers

  • Premium-quality APIs and excipients

  • Batch-to-batch consistency

  • Comprehensive quality testing at every production stage

Global Presence & Supply Chain Support

  • Timely delivery to international markets

  • Flexible minimum order quantities for distributors

  • Assistance with export documentation

  • Long-term supply agreements for consistent availability

Top 20 Countries Exporting Stiripentol Capsule 500mg

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 Details
Product Name Stiripentol Capsule 500mg
Active Ingredient Stiripentol
Therapeutic Class Anti-Epileptic
Dosage Form Hard Gelatin Capsule
Strength 500mg
Packaging Blister Packs / Bottles
Shelf Life 24–36 Months
Storage Below 25°C, Dry Place
Manufacturing Location Vapi, Gujarat, India
Certification WHO-GMP, ISO
Availability PAN India & Export

PAN India Manufacturing, Supply & PCD Franchise Opportunities

Taj Pharma is widely recognized as:

  • Stiripentol Capsule 500mg PAN India Manufacturer

  • Stiripentol Capsule 500mg Manufacturer Supplier and PCD Pharma Franchise

  • Stiripentol Capsule 500mg Manufacturer from Mumbai

  • Stiripentol Capsule 500mg Manufacturer Vapi, Gujarat

  • Stiripentol Capsule 500mg Best Price in Mumbai Maharashtra – Taj Pharma

  • Leading 1 Stiripentol Capsule 500mg Manufacturer & Supplier in India


Call to Action  

Global buyers, importers, and distributors looking for a trusted Stiripentol Capsule 500mg Manufacturer in India can rely on Taj Pharma for:

  • High-quality product samples

  • Competitive pricing and export quotations

  • Complete regulatory dossiers and certifications

  • PCD franchise and distribution opportunities

Contact Taj Pharma today to establish a long-term business partnership.


Top 20 FAQs 

  1. What is Stiripentol Capsule 500mg used for?
    Used for seizures in Dravet syndrome.

  2. Is Taj Pharma WHO-GMP certified?
    Yes.

  3. Can Stiripentol be exported?
    Yes, worldwide.

  4. What is the shelf life?
    24–36 months.

  5. Is private labeling available?
    Yes.

  6. Can it be used in children?
    Yes, from 6 months of age.

  7. Does Taj Pharma provide COPP?
    Yes.

  8. What packaging options are available?
    Blister packs and bottles.

  9. Is EU-GMP certification available?
    Yes.

  10. Where is Taj Pharma located?
    Vapi, Gujarat, India.

  11. Is a prescription required?
    Yes.

  12. Can it be taken with food?
    Yes.

  13. Does Taj Pharma export to Africa?
    Yes.

  14. Are bulk orders accepted?
    Yes.

  15. Is in-house quality testing performed?
    Yes.

  16. Are CTD dossiers available?
    Yes.

  17. Is MOQ flexible?
    Yes.

  18. Does Taj Pharma support tender supplies?
    Yes.

  19. Is Mumbai supply available?
    Yes.

  20. How can buyers contact Taj Pharma?
    Through official export inquiry channels.