Amitriptyline Hydrochloride Tablets 25mg

Amitriptyline Hydrochloride Tablets 25mg 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 25mg

Amitriptyline Hydrochloride Tablets 25mg are widely prescribed oral solid dosage forms belonging to the class of tricyclic antidepressants (TCAs). These tablets are FDA-approved for the treatment of depression in adults and are also extensively used off-label for managing chronic pain syndromes, anxiety disorders, insomnia, migraine, neuropathic pain, bed-wetting (enuresis), and obsessive-compulsive disorder (OCD).

Globally, the demand for Amitriptyline Hydrochloride Tablets 25mg continues to rise due to increasing awareness of mental health disorders, growing prevalence of chronic pain conditions, and the need for cost-effective antidepressant therapies. As a lower-dose strength, 25mg tablets are especially preferred for initial therapy, dose titration, geriatric patients, and long-term pain management protocols.

Taj Pharma, the well-known Amitriptyline Hydrochloride Tablets 25mg manufacturer in India, assures high quality, purity, safety, and regulatory compliance, making it a preferred partner for importers, distributors, hospitals, and government tenders worldwide.

About Amitriptyline Hydrochloride – Mechanism of Action & Clinical Benefits

Amitriptyline is a tricyclic antidepressant with anticholinergic and sedative properties. It works by preventing the reuptake and inactivation of neurotransmitters such as noradrenaline and serotonin at nerve terminals in the brain. By increasing the availability of these monoamine neurotransmitters, Amitriptyline enhances neurotransmission, thereby improving mood and emotional balance.

Additionally, Amitriptyline blocks pain signal transmission from nerves to the brain, making it highly effective in treating neuropathic pain and migraine prophylaxis. These pharmacological actions explain its widespread use in both psychiatric and neurological conditions.

 Trusted Manufacturer, Exporter & Supplier from India

Taj Pharma Ltd., based in Vapi, Gujarat, India, is a well-established Manufacturer, Exporter, and Supplier of Amitriptyline Hydrochloride Tablets 25mg. The company has built a strong reputation across domestic and international markets by consistently delivering WHO-GMP compliant pharmaceutical formulations.

Taj Pharma’s Amitriptyline Hydrochloride Tablets 25mg are manufactured under stringent quality control systems, ensuring batch-to-batch consistency, safety, efficacy, and extended shelf-life.

Clinical Uses of Amitriptyline Hydrochloride Tablets 25mg

Amitriptyline Hydrochloride Tablets 25mg are commonly used for:

• Depression

• Anxiety disorders

• Neuropathic pain

• Migraine prevention

• Insomnia

• Obsessive-compulsive disorder (OCD)

• Bed-wetting (enuresis)

• Chronic pain syndromes

It may take 4 to 6 weeks for Amitriptyline to show its full antidepressant effect. Patients are advised to continue therapy as prescribed and take the medicine preferably at bedtime due to its sedative effects.

Important precautions:

• Avoid alcohol consumption during treatment

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

• Avoid driving or operating machinery until individual response is known

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma supports international buyers with complete regulatory documentation, including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• EU-GMP (on request)

• Free Sale Certificate

• Stability Data

• Method of Analysis (MOA)

• Certificate of Analysis (COA)

• CTD Dossier (Modules 1–5 as required)

Custom Packaging & Labeling

• Alu-Alu blister packs

• PVC blister packs

• HDPE containers

• Bulk packing for tenders

• Private labeling & multilingual artworks

Shelf-Life, Storage & Dosage Form

• Dosage Form: Film-coated tablets

• Strength: 25mg

• Shelf-life: 24–36 months

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

Export Certifications

• WHO-GMP Manufacturing Facility

• ISO Certified Operations

• GDP-compliant logistics

• Pharmacovigilance support

Target Countries & Export Markets

Taj Pharma exports Amitriptyline Hydrochloride Tablets 25mg to regulated, semi-regulated, and emerging markets across Asia, Africa, CIS, Latin America, and the Middle East.

Why Taj Pharma is the Most Trusted Amitriptyline Hydrochloride Tablets 25mg Manufacturer in India

State-of-the-Art Manufacturing

• Advanced production lines

• Automated quality inspection systems

• In-house QA/QC laboratories

Affordable Pricing & Quality Assurance

• Competitive export pricing

• Stringent quality checks at every stage

• Compliance with global pharmacopeial standards

Global Presence & Supply Chain Support

• Reliable logistics partners

• Timely delivery schedules

• Dedicated export documentation team

Top 20 Exporting Countries Served

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 Table

Call to Action 

If you are looking for a Leading   Amitriptyline Hydrochloride Tablets 25mg Manufacturer & Supplier in India, Taj Pharma is your trusted partner. Contact us today for export inquiries, bulk supply, PCD Pharma Franchise opportunities, and private labeling solutions.

Top 20 FAQs 

1. What is Amitriptyline Hydrochloride Tablets 25mg used for?
   Used for depression, neuropathic pain, anxiety, migraine, and insomnia.

2. Is Taj Pharma a WHO-GMP manufacturer?
   Yes, Taj Pharma is WHO-GMP certified.

3. Can Amitriptyline 25mg cause sleepiness?
   Yes, it has sedative effects and is usually taken at bedtime.

4. How long does it take to work?
   Typically 4–6 weeks for full antidepressant effect.

5. Does Taj Pharma export globally?
   Yes, to over 20 countries worldwide.

6. Is custom packaging available?
   Yes, private labeling and customized packaging are offered.

7. What is the shelf-life?
   24 to 36 months.

8. Can alcohol be consumed?
   No, alcohol should be avoided.

9. Is weight gain possible?
   Yes, increased appetite and weight gain may occur.

10. Is it safe for long-term use?
    As prescribed by a physician.

11. Is a CTD dossier available?
    Yes, on request.

12. Is this product FDA-approved?
    The API is FDA-approved.

13. Can it treat neuropathic pain?
    Yes, very effectively.

14. Is this suitable for export tenders?
    Yes, tender-ready documentation available.

15. What dosage forms are available?
    Primarily oral tablets.

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

17. Is PCD Pharma Franchise available?
    Yes.

18. Are stability studies conducted?
    Yes, as per ICH guidelines.

19. Is MOQ flexible?
    Yes, depending on market.

20. How to place an order?
    Contact Taj Pharma’s export team directly.