Amitriptyline Hydrochloride Tablets 50mg

Amitriptyline Hydrochloride Tablets 50mg 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 50mg

Amitriptyline Hydrochloride Tablets 50mg are a widely prescribed tricyclic antidepressant (TCA) used for the effective management of depression and various neurological and psychological disorders. FDA-approved for treating depression in adults, Amitriptyline is also extensively prescribed off-label for chronic pain syndromes, anxiety disorders, insomnia, migraine prevention, obsessive-compulsive disorder (OCD), neuropathic pain, and bed-wetting (enuresis).

With the growing global burden of mental health conditions, sleep disorders, and nerve-related pain, the demand for Amitriptyline Hydrochloride Tablets 50mg continues to rise across both developed and emerging markets. Many international buyers rely on Indian pharmaceutical manufacturers due to their ability to deliver cost-effective, high-quality, and WHO-GMP compliant formulations.

Taj Pharma, a well-known Amitriptyline Hydrochloride Tablets 50mg Manufacturer in India, assures exceptional quality, high purity, and consistent therapeutic performance. Manufactured at its advanced facility in Vapi, Gujarat, Taj Pharma supplies this essential antidepressant to PAN India markets and exports globally.

 Trusted Amitriptyline Hydrochloride Tablets 50mg Manufacturer in India

Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Amitriptyline Hydrochloride Tablets 50mg from Vapi, Gujarat, India. The company strictly adheres to WHO-GMP guidelines, ensuring that every tablet meets international standards of safety, efficacy, and stability.

Amitriptyline Hydrochloride Tablets 50mg are commonly used in the treatment of:

• Depression

• Anxiety disorders

• Neuropathic pain

• Migraine prophylaxis

• Insomnia

• Obsessive-compulsive disorder

• Bed-wetting

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

Mechanism of Action & Therapeutic Advantages

Amitriptyline Hydrochloride Tablets 50mg act by inhibiting the reuptake of key neurotransmitters—noradrenaline and serotonin—at nerve endings in the brain. This mechanism increases their availability in the synaptic cleft, enhancing neurotransmission.

Key therapeutic benefits include:

• Improved mood stabilization

• Reduction in anxiety symptoms

• Effective relief from neuropathic pain by blocking pain signal transmission

• Improved sleep quality due to sedative effects

Taj Pharma’s advanced formulation ensures excellent bioavailability, uniform dissolution, and consistent clinical outcomes, making it a preferred product for healthcare professionals and importers worldwide.

Dosage, Safety & Patient Advisory

Amitriptyline Hydrochloride Tablets 50mg should be taken strictly as prescribed by a physician. Patients should be advised that:

• It may take 4 to 6 weeks to observe full antidepressant effects

• The medicine may cause sleepiness or dizziness, so bedtime dosing is recommended

• Driving or operating machinery should be avoided until individual response is known

Additional precautions include:

• Avoid alcohol to prevent excessive sedation

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

• Do not discontinue the medication abruptly without medical consultation

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

As a globally trusted Amitriptyline Hydrochloride Tablets 50mg Supplier, Taj Pharma provides complete regulatory support, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• ISO Certification

• Certificate of Analysis (COA)

• Stability Study Data

• Batch Manufacturing Records

• CTD / ACTD Dossiers

Custom Packaging & Labeling

Taj Pharma offers flexible and market-specific packaging solutions:

• Alu-Alu and PVC blister packs

• HDPE bottle packaging

• Country-specific artwork and labeling

• Multilingual pack inserts

• Private labeling and PCD Pharma Franchise opportunities

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 50mg

• Shelf Life: 24–36 months

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

Export Certifications

• WHO-GMP Certified Manufacturer in India

• ISO Certified Facilities

• EU-GMP documentation support (on request)

• GDP-compliant logistics and cold-chain management

Target Countries & Export Markets

Taj Pharma exports Amitriptyline Hydrochloride Tablets 50mg from India to:

• Africa

• Southeast Asia

• Middle East

• Latin America

• CIS Countries

• Selected European and Asian markets

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

State-of-the-Art Manufacturing Facilities

Taj Pharma operates advanced pharmaceutical manufacturing units in Vapi featuring:

• cGMP-compliant production lines

• Automated tablet compression and coating machines

• In-house quality control and microbiology labs

• Experienced formulation and regulatory professionals

Affordable Pricing & Quality Assurance

As a Leading #1 Amitriptyline Hydrochloride Tablets 50mg Manufacturer in India, Taj Pharma offers:

• Highly competitive export pricing

• Strict batch-to-batch consistency

• Compliance with IP, BP, and USP standards

Global Presence & Supply Chain Excellence

• Strong international logistics network

• On-time delivery across continents

• Dedicated export documentation and after-sales support

Top 20 Countries Taj Pharma Exports To

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification 

Call to Action 

If you are seeking a reliable Amitriptyline Hydrochloride Tablets 50mg Manufacturer & Supplier in India, 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 pricing, samples, regulatory dossiers, and long-term international supply agreements.

Top 20 FAQs 

1. What is Amitriptyline Hydrochloride Tablets 50mg used for?
   Depression, anxiety, neuropathic pain, and insomnia.

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

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

4. Is this a prescription-only medicine?
   Yes.

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

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

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

8. Does Taj Pharma provide COPP?
   Yes.

9. Is bulk export available?
   Yes.

10. What packaging options are offered?
    Blister and bottle packs.

11. Is private labeling available?
    Yes.

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

13. Is it effective for neuropathic pain?
    Yes.

14. Can treatment be stopped suddenly?
    No.

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

16. Is it suitable for elderly patients?
    Under medical supervision.

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

18. Does Taj Pharma export worldwide?
    Yes.

19. Are CTD dossiers available?
    Yes.

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