Amitriptyline Hydrochloride Tablets 75mg

Amitriptyline Hydrochloride Tablets  75mg 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 75mg

Amitriptyline Hydrochloride Tablets 75mg are a widely prescribed tricyclic antidepressant (TCA) used in the treatment of depression and multiple neurological and psychological conditions. FDA-approved for treating depression in adults, Amitriptyline is also commonly prescribed off-label for chronic pain syndromes, anxiety disorders, insomnia, migraine prevention, obsessive-compulsive disorder (OCD), neuropathic pain, and bed-wetting.

With the global rise in mental health disorders, chronic stress, and nerve-related pain conditions, the demand for Amitriptyline Hydrochloride Tablets 75mg has increased significantly. Many countries rely on Indian pharmaceutical manufacturers for cost-effective, high-quality, and regulatory-compliant medicines.

Taj Pharma, a well-known Amitriptyline Hydrochloride Tablets 75mg Manufacturer in India, assures high-quality, purity, safety, and therapeutic consistency. Manufactured at its advanced facility in Vapi, Gujarat, Taj Pharma supplies this essential medicine to domestic and international markets with complete regulatory compliance.

 Trusted Amitriptyline Hydrochloride Tablets 75mg Manufacturer in India

Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Amitriptyline Hydrochloride Tablets 75mg from Vapi, Gujarat, India. The company follows stringent WHO-GMP manufacturing standards, ensuring consistent quality across every production batch.

Amitriptyline Hydrochloride Tablets 75mg are commonly used in the treatment of:

• Depression

• Anxiety disorders

• Neuropathic pain

• Migraine prophylaxis

• Insomnia

• Obsessive-compulsive disorder

• Bed-wetting (enuresis)

As a tricyclic antidepressant, Amitriptyline exhibits anticholinergic and sedative properties, making it particularly effective for patients with depression accompanied by sleep disturbances or chronic pain.

Mechanism of Action & Clinical Benefits

Amitriptyline Hydrochloride Tablets 75mg work by inhibiting the reuptake of key neurotransmitters—noradrenaline and serotonin—at nerve terminals in the brain. By preventing their inactivation, the medicine increases the availability of these neurotransmitters, enhancing communication between nerve cells.

This action:

• Improves mood regulation

• Reduces symptoms of depression

• Helps control anxiety

• Relieves neuropathic pain by blocking pain signal transmission from damaged nerves

Taj Pharma’s formulation ensures optimal bioavailability, uniform dissolution, and consistent therapeutic outcomes, making it a preferred choice among healthcare providers and global buyers.

Dosage, Safety & Patient Guidance

Amitriptyline Hydrochloride Tablets 75mg should be taken strictly as prescribed by a healthcare professional. Patients should be informed that:

• Therapeutic effects may take 4 to 6 weeks to become noticeable

• The medicine may cause sleepiness, so it is best taken at bedtime

• Driving or operating heavy machinery should be avoided until its effects are known

Additional precautions:

• Avoid alcohol consumption to prevent excessive drowsiness

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

• Do not stop treatment abruptly without medical advice

In-Depth Information for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

As a globally trusted Amitriptyline Hydrochloride Tablets 75mg Supplier, Taj Pharma provides comprehensive regulatory documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• ISO Certification

• Certificate of Analysis (COA)

• Stability Data

• Batch Manufacturing Records

• CTD / ACTD Dossiers for regulated and semi-regulated markets

Custom Packaging & Labeling

Taj Pharma offers customized packaging solutions tailored to market requirements:

• PVC-Alu and Alu-Alu blister packs

• HDPE bottle packaging

• Country-specific labeling

• Multilingual packaging support

• Private labeling and PCD Pharma Franchise opportunities

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 75mg

• Shelf Life: 24–36 months

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

Export Certifications

• WHO-GMP Certified Manufacturer in India

• ISO-Certified Facilities

• EU-GMP documentation support (on request)

• GDP-compliant export logistics

Target Countries & Export Markets

Taj Pharma exports Amitriptyline Hydrochloride Tablets 75mg from India to:

• Africa

• Southeast Asia

• Middle East

• Latin America

• CIS Countries

• Select European and Asian markets

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

State-of-the-Art Manufacturing

Taj Pharma operates modern pharmaceutical facilities in Vapi featuring:

• cGMP-compliant production units

• Automated tablet compression and coating systems

• In-house quality control laboratories

• Highly experienced technical and regulatory teams

Affordable Pricing & Quality Assurance

As a Leading #1 Amitriptyline Hydrochloride Tablets 75mg Manufacturer in India, Taj Pharma delivers:

• Competitive export pricing

• High batch-to-batch consistency

• Compliance with IP, BP, and USP standards

Global Presence & Supply Chain Support

• Strong international logistics network

• Timely order fulfillment

• Dedicated export documentation and customer support

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 searching for a Amitriptyline Hydrochloride Tablets 75mg Manufacturer & Supplier in India with proven export expertise, Taj Pharma is your ideal pharmaceutical partner. We support bulk supply, contract manufacturing, regulated-market exports, and PCD Pharma Franchise opportunities.

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

Top 20 FAQs  

1. What is Amitriptyline Hydrochloride Tablets 75mg used for?
   Depression, anxiety, neuropathic pain, and insomnia.

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

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

4. Is it a prescription medicine?
   Yes.

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

6. Can it cause drowsiness?
   Yes, sedation is common.

7. Is alcohol safe with Amitriptyline?
   No, it should be avoided.

8. Does Taj Pharma provide COPP?
   Yes.

9. Can it be exported globally?
   Yes.

10. What packaging options are available?
    Blister and bottle packaging.

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 Taj Pharma WHO-GMP certified?
    Yes.

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