GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Dothiepin Hydrochloride Tablets IP 25mg
B) Dothiepin Hydrochloride Tablets IP 50mg
C) Dothiepin Hydrochloride Tablets IP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Dothiepin Hydrochloride Tablets IP 25mg
Each Film coated tablet contains:
Dothiepin Hydrochloride IP……….……25mg
Excipients…………………………………...q.s.
Colours: Lake brilliant blue

B) Dothiepin Hydrochloride Tablets IP 50mg
Each Film coated tablet contains:
Dothiepin Hydrochloride IP………………50mg
Excipients……………………………………………...q.s.
Colours: Ferric oxide yellow


C) Dothiepin Hydrochloride Tablets IP 75mg
Each Film coated tablet contains:
Dothiepin Hydrochloride IP…………………75mg
Excipients……………………………………………q.s.
Colours: Brilliant blue FCF

THERAPEUTIC INDICATIONS:

Dothiepin is used in the treatment of anxiety disorder and depression. It is used in patient’s intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: 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

Dothiepin Hydrochloride Tablets 50mg Technical Specification:

Product Name: Dothiepin Hydrochloride Tablets IP
Brand Name: Generic
Strength: 25mg, 50mg, 75mg
Dosage Form: Tablets (Film coated)
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: Antidepressants, Central nervous system
Indication: It is used to treat symptoms of depression (low mood) such as: Feeling sad. Feeling hopeless or worthless.
Storage: Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Dothiepin Hydrochloride Tablets IP 25mg
  • B) Dothiepin Hydrochloride Tablets IP 50mg
  • C) Dothiepin Hydrochloride Tablets IP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Dothiepin Hydrochloride Tablets IP 25mg
    Each Film coated tablet contains:
    Dothiepin Hydrochloride IP……….……25mg
    Excipients……………………………………q.s.
    Colours: Lake brilliant blue
  • B) Dothiepin Hydrochloride Tablets IP 50mg
    Each Film coated tablet contains:
    Dothiepin Hydrochloride IP………………50mg
    Excipients………………………………………………q.s.
    Colours: Ferric oxide yellow
  • C) Dothiepin Hydrochloride Tablets IP 75mg
    Each Film coated tablet contains:
    Dothiepin Hydrochloride IP…………………75mg
    Excipients……………………………………………q.s.
    Colours: Brilliant blue FCF

THERAPEUTIC INDICATIONS:

  • Dothiepin is used in the treatment of anxiety disorder and depression. It is used in patients intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.

CAUTION & SCHEDULE:

  • CAUTION:
    Read enclosed leaflet before use.Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE: SCHEDULE H: 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 Dothiepin Hydrochloride Tablets 50mg

Dothiepin Hydrochloride Tablets 50mg is a tricyclic antidepressant widely prescribed for patients suffering from depression that is unresponsive to alternative treatments. It is also used for managing anxiety disorders. The medication functions by increasing the levels of chemical messengers in the brain, thereby stabilizing mood and alleviating symptoms of depression and anxiety.

Taj Pharma, a trusted Dothiepin Hydrochloride Tablets 50mg manufacturer in India, ensures high-quality production with stringent quality control standards. The medication is typically taken before bedtime due to its sedative effects and can be consumed with or without food. For optimal efficacy, it is essential to take it at a fixed time each day.

Globally, there is a growing demand for Dothiepin Hydrochloride Tablets 50mg owing to the rising prevalence of mental health disorders, increasing awareness of depression treatment, and the need for reliable and cost-effective tricyclic antidepressants. Taj Pharma’s excellence in manufacturing, regulatory compliance, and international supply has established it as a leading exporter in this segment.


In-Depth Details for Importers, Exporters, and Global Buyers

Regulatory Documentation Provided

To facilitate international trade, Taj Pharma provides comprehensive documentation with every batch of Dothiepin Hydrochloride Tablets 50mg, including:

  • Certificate of Analysis (CoA)

  • Free Sale Certificate (FSC)

  • GMP Compliance Certificate

  • Drug Master File (DMF)

  • Product registration dossiers for various markets

This ensures that global buyers have all necessary paperwork for smooth customs clearance and regulatory compliance.

Custom Packaging & Labeling

Taj Pharma offers customized packaging solutions to meet diverse international market needs:

  • Blister packs, strip packs, and bulk packaging

  • Multilingual labeling for global distribution

  • Private labeling for PCD Pharma franchise partners

Custom packaging allows distributors to market the product under their own brand while adhering to regulatory standards.

Shelf-Life, Storage, and Dosage Form

Dothiepin Hydrochloride Tablets 50mg comes in oral tablet form with a shelf-life of 24 months. Proper storage and administration are crucial for maintaining efficacy:

  • Store in a cool, dry place away from sunlight

  • Take at the same time every day for consistent blood levels

  • Complete the full prescribed course even if symptoms improve

  • Do not stop suddenly; gradual dose tapering may be necessary under medical supervision

Export Certifications

As a WHO-GMP manufacturer in India, Taj Pharma holds essential certifications ensuring global compliance:

  • WHO-GMP (World Health Organization – Good Manufacturing Practices)

  • EU-GMP (European Union – Good Manufacturing Practices)

  • COPP (Certificate of Pharmaceutical Product)

  • CTD Dossier (Common Technical Document for Registration)

These certifications allow importers to confidently source Dothiepin Hydrochloride Tablets 50mg for distribution worldwide.

Target Countries & Export Markets

Taj Pharma exports Dothiepin Hydrochloride Tablets 50mg to more than 20 countries globally, including:

  • USA

  • UK

  • Germany

  • Australia

  • UAE

  • Saudi Arabia

  • South Africa

  • Canada

  • Singapore

  • New Zealand

  • Kenya

  • Nigeria

  • Bangladesh

  • Sri Lanka

  • Philippines

  • Malaysia

  • Russia

  • Egypt

  • Thailand

  • Indonesia

This global footprint demonstrates Taj Pharma’s reliability in supplying high-quality medication consistently.


Why is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

Taj Pharma’s manufacturing facility in Vapi, Gujarat, is equipped with modern production lines, automated machinery, and advanced quality control laboratories. Every batch of Dothiepin Hydrochloride Tablets 50mg is rigorously tested to ensure purity, safety, and efficacy.

Affordable Pricing & Quality Assurance

Taj Pharma combines affordability with uncompromising quality:

  • Rigorous chemical, physical, and microbiological testing

  • Stability and packaging checks for each batch

  • Competitive pricing for domestic and international buyers

This ensures buyers receive premium medication at cost-effective rates.

Global Presence & Supply Chain Support

With an established logistics and supply chain network, Taj Pharma guarantees:

  • Timely delivery across international markets

  • Efficient handling of export documentation

  • Long-term support for hospitals, distributors, and PCD franchise holders

Top 20 Countries Exporting

Taj Pharma exports Dothiepin Hydrochloride Tablets 50mg to:

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:  

Attribute Specification
Product Name Dothiepin Hydrochloride Tablets 50mg
Active Ingredient Dothiepin Hydrochloride
Strength 50mg per tablet
Dosage Form Oral Tablet
Color & Shape White, Round
Packing Blister packs, 10×10 or customized
Shelf Life 24 months
Storage Cool, dry place, away from sunlight
Indication Depression, Anxiety Disorders
Manufacturer Taj Pharma Ltd, Vapi, Gujarat, India
Certifications WHO-GMP, EU-GMP, COPP, CTD Dossier
Export Markets PAN India & 20+ International countries

How to Order Dothiepin Hydrochloride Tablets 50mg  

Buyers, distributors, and PCD franchise holders can directly contact Taj Pharma for bulk orders of Dothiepin Hydrochloride Tablets 50mg. The company offers:

  • Competitive bulk pricing

  • Custom packaging and labeling for international markets

  • PCD franchise opportunities

  • Timely supply and reliable delivery

Contact Taj Pharma today to secure a trusted supply of Dothiepin Hydrochloride Tablets 50mg for hospitals, pharmacies, and distributors.


Top 20 FAQs 

  1. What is Dothiepin Hydrochloride Tablets 50mg used for?
    Treats depression and anxiety disorders.

  2. Can it be taken with food?
    Yes, with or without food.

  3. What is the recommended dosage?
    Dose is decided by a physician according to patient needs.

  4. Can this medicine be stopped abruptly?
    No, gradual tapering under doctor supervision is necessary.

  5. What are common side effects?
    Dry mouth, blurred vision, constipation, dizziness, drowsiness, weight gain.

  6. Is Taj Pharma WHO-GMP certified?
    Yes, the facility adheres to WHO-GMP standards.

  7. Is custom packaging available for export?
    Yes, multilingual labeling and private branding are provided.

  8. What is the shelf-life of Dothiepin Hydrochloride Tablets 50mg?
    24 months from manufacture.

  9. How should the medicine be stored?
    In a cool, dry place, away from sunlight.

  10. Which countries does Taj Pharma export to?
    Over 20 countries including USA, UK, Germany, UAE, and Australia.

  11. Can pregnant women take this medication?
    Only with medical supervision and caution.

  12. Does this medication cause weight gain?
    Some patients may experience mild weight gain; lifestyle adjustments help.

  13. Is it safe for elderly patients?
    Yes, with adjusted dosing and supervision.

  14. Can it interact with alcohol?
    Alcohol should be avoided as it can cause serious complications.

  15. Is it addictive?
    Not known to be addictive, but withdrawal symptoms may occur if stopped suddenly.

  16. How should it be taken for best results?
    At a fixed time daily, preferably before bedtime.

  17. What if a dose is missed?
    Take it as soon as remembered; do not double the dose.

  18. Are serious side effects common?
    Rare, but monitor for mood changes or suicidal thoughts.

  19. Does Taj Pharma offer PCD Pharma franchise?
    Yes, nationwide franchise opportunities are available.

  20. How can buyers place bulk orders?
    Contact Taj Pharma via official website, email, or phone.