Amitriptyline Hydrochloride Tablets 100mg

Amitriptyline Hydrochloride Tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Amitriptyline Hydrochloride Tablets USP 10mg
B) Amitriptyline Hydrochloride Tablets USP 25mg
C) Amitriptyline Hydrochloride Tablets USP 50mg
D) Amitriptyline Hydrochloride Tablets USP 75mg
E) Amitriptyline Hydrochloride Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Amitriptyline Hydrochloride Tablets USP 10mg
Each film coated chewable tablet contains:
Amitriptyline Hydrochloride USP……………………..10mg
Excipients………………………………………………………….q.s.
Colour: Red Oxide of Iron

B) Amitriptyline Hydrochloride Tablets USP 25mg
Each film coated chewable tablet contains:
Amitriptyline Hydrochloride USP………………..25mg
Excipients……………………………………………………q.s.
Colour: Ponceau 4 R

C) Amitriptyline Hydrochloride Tablets USP 50mg
Each film coated chewable tablet contains:
Amitriptyline Hydrochloride USP………………….50mg
Excipients……………………………………………………..q.s.
Colour: Quinoline yellow

D) Amitriptyline Hydrochloride Tablets USP 75mg
Each film coated chewable tablet contains:
Amitriptyline Hydrochloride USP………………….75mg
Excipients………………………………………………………q.s.
Colour: Lake of Erythrosine

E) Amitriptyline Hydrochloride Tablets USP 100mg
Each film coated chewable tablet contains:
Amitriptyline Hydrochloride USP……………..100mg
Excipients…………………………………………………q.s.
Colour: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Amitriptyline is used to treat mental/mood problems such as depression. It may help improve mood and feelings of well-being, relieve anxiety and tension, help you sleep better, and increase your energy level. This medication belongs to a class of medications called tricyclic antidepressants. It works by affecting the balance of certain natural chemicals (neurotransmitters such as serotonin) in the brain.

CAUTION & WARNING:

CAUTION: 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) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Amitriptyline Hydrochloride Tablets 100mg

Amitriptyline Hydrochloride Tablets 100mg are a widely prescribed tricyclic antidepressant (TCA) used primarily for the treatment of depression in adults. Approved by the FDA, Amitriptyline is also extensively prescribed off-label for chronic pain syndromes, anxiety disorders, insomnia, migraines, neuropathic pain, and bed-wetting in children under medical supervision.

Globally, the demand for Amitriptyline Hydrochloride Tablets 100mg continues to rise due to the increasing prevalence of mental health disorders, stress-related illnesses, and chronic pain conditions. Developing and emerging markets especially rely on Indian pharmaceutical manufacturers for consistent quality, cost efficiency, and regulatory compliance.

Taj Pharma, a well-known Amitriptyline Hydrochloride Tablets 100mg Manufacturer in India, assures unmatched quality, purity, and therapeutic efficacy. With modern manufacturing facilities in Vapi, Gujarat, Taj Pharma stands as a reliable Manufacturer, Exporter, and Supplier trusted by global pharmaceutical buyers.

  Trusted Amitriptyline Hydrochloride Tablets 100mg Manufacturer in India

Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Amitriptyline Hydrochloride Tablets 100mg from Vapi, Gujarat, India. The company adheres strictly to WHO-GMP guidelines, ensuring every tablet meets international safety and quality standards.

Amitriptyline Hydrochloride Tablets 100mg are commonly used in the treatment of:

• Depression

• Anxiety disorders

• Neuropathic pain

• Migraine prophylaxis

• Obsessive-compulsive disorder (OCD)

• Insomnia

• Bed-wetting (enuresis)

As a tricyclic antidepressant, Amitriptyline has anticholinergic and sedative properties, making it effective in mood regulation and pain relief.

Mechanism of Action & Therapeutic Benefits

Amitriptyline Hydrochloride Tablets 100mg work by preventing the reuptake of neurotransmitters such as noradrenaline and serotonin at nerve terminals in the brain. By inhibiting their reabsorption, Amitriptyline increases their availability, enhancing neurotransmission and improving mood stability.

This mechanism is closely linked to its antidepressant action. Additionally, Amitriptyline blocks pain signal transmission from damaged nerves to the brain, making it highly effective in neuropathic pain management.

Taj Pharma’s formulation ensures:

• Optimal bioavailability

• Consistent therapeutic response

• Reduced variability between batches

Dosage, Safety & Patient Information

Amitriptyline Hydrochloride Tablets 100mg should be taken exactly as prescribed. It may take 4 to 6 weeks for noticeable therapeutic effects, especially in depression.

Important precautions include:

• Take the medicine at bedtime due to its sedative effect

• Avoid driving or operating machinery until its effects are known

• Avoid alcohol, as it can cause excessive drowsiness

• Monitor weight regularly, as increased appetite and weight gain may occur

Patients should continue treatment as prescribed and not discontinue abruptly.

In-Depth Information for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

As a globally trusted Amitriptyline Hydrochloride Tablets 100mg Supplier, Taj Pharma provides complete regulatory documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• ISO Certification

• Certificate of Analysis (COA)

• Stability Data

• CTD / ACTD Dossier

• Batch Manufacturing Records

Custom Packaging & Labeling

Taj Pharma offers flexible, market-specific packaging options:

• Alu-Alu and PVC-Alu blister packs

• HDPE bottle packaging

• Country-specific artwork and multilingual labeling

• Private labeling & PCD Pharma Franchise solutions

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 100mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, protect from light and moisture

Export Certifications

• WHO-GMP Manufacturer India

• ISO Certified Facilities

• EU-GMP documentation support (on request)

• GDP-compliant export logistics

Target Countries & Export Markets

Taj Pharma exports Amitriptyline Hydrochloride Tablets 100mg from India to:

• Africa

• Southeast Asia

• Middle East

• Latin America

• CIS Countries

• Select European markets

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

State-of-the-Art Manufacturing

Taj Pharma’s advanced facilities in Vapi feature:

• cGMP-compliant production units

• Automated tablet compression and coating

• In-house quality testing laboratories

• Highly experienced pharmaceutical professionals

Affordable Pricing & Quality Assurance

As a Leading #1 Amitriptyline Hydrochloride Tablets 100mg Manufacturer in India, Taj Pharma offers:

• Competitive export pricing

• Consistent batch quality

• Compliance with IP, BP, and USP standards

Global Presence & Supply Chain Support

• Reliable international logistics

• On-time delivery

• Dedicated regulatory and export teams

Top 20 Countries Taj Pharma Exports To

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  

Call to Action  

If you are looking for a Amitriptyline Hydrochloride Tablets 100mg Manufacturer & Supplier in India with proven export expertise, Taj Pharma is your ideal partner. We support bulk supply, regulated-market exports, and PCD Pharma Franchise opportunities with full regulatory assistance.

👉 Contact Taj Pharma today for export pricing, samples, dossiers, and long-term supply contracts.

Top 20 FAQs  

1. What is Amitriptyline Hydrochloride Tablets 100mg used for?
   Depression, anxiety, neuropathic pain, and insomnia.

2. Is it FDA-approved?
   Yes, for depression in adults.

3. Who is the best Amitriptyline manufacturer in India?
   Taj Pharma.

4. Is it prescription-only?
   Yes.

5. How long does it take to work?
   4–6 weeks.

6. Can it cause drowsiness?
   Yes.

7. Is alcohol safe with Amitriptyline?
   No.

8. Does Taj Pharma provide COPP?
   Yes.

9. Can it be exported globally?
   Yes.

10. What packaging is available?
    Blister and bottle packs.

11. Is private labeling available?
    Yes.

12. Does it cause weight gain?
    It may increase appetite.

13. Is bulk supply possible?
    Yes.

14. Is it suitable for neuropathic pain?
    Yes.

15. Does Taj Pharma provide CTD dossiers?
    Yes.

16. How should it be stored?
    Below 25°C.

17. Is it safe for elderly patients?
    With medical supervision.

18. Can treatment be stopped suddenly?
    No.

19. Is it WHO-GMP certified?
    Yes.

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