Amitriptyline Hydrochloride Tablets 10mg

Amitriptyline Hydrochloride Tablets 10mg 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 10mg

Amitriptyline Hydrochloride Tablets 10mg are an essential pharmaceutical formulation belonging to the tricyclic antidepressant (TCA) class. This lower-dose strength is widely prescribed for initiation therapy, dose titration, elderly patients, and long-term management of chronic neurological and psychiatric conditions. Amitriptyline is FDA-approved for the treatment of depression in adults and is extensively used off-label for chronic pain syndrome, anxiety disorders, insomnia, migraine prophylaxis, neuropathic pain, obsessive-compulsive disorder (OCD), and bed-wetting (enuresis).

The global demand for Amitriptyline Hydrochloride Tablets 10mg is steadily increasing due to the rising prevalence of mental health disorders, sleep-related conditions, and chronic pain illnesses. Healthcare professionals prefer the 10mg strength for its flexibility, safety, and tolerability, especially in sensitive patient populations.

Taj Pharma, the well-known Amitriptyline Hydrochloride Tablets 10mg manufacturer in India, provides unmatched assurance of high-quality manufacturing, purity, stability, and regulatory compliance, making it a trusted partner for international buyers.

About Amitriptyline Hydrochloride – Pharmacology & Therapeutic Value

Amitriptyline is a tricyclic antidepressant with anticholinergic and sedative properties. It works by inhibiting the reuptake of monoamine neurotransmitters, specifically noradrenaline and serotonin, at synaptic nerve endings in the brain. This reuptake inhibition increases neurotransmitter availability, thereby enhancing mood stabilization and emotional regulation.

In addition to its antidepressant effects, Amitriptyline blocks pain signal transmission from peripheral nerves to the brain, which explains its widespread use in neuropathic pain, fibromyalgia, and migraine prevention. Its sedative action also makes it effective in managing sleep disorders and anxiety-related insomnia.

 Trusted Amitriptyline Hydrochloride Tablets 10mg Manufacturer in India

Taj Pharma Ltd. India is a well-established Manufacturer, Exporter, and Supplier of Amitriptyline Hydrochloride Tablets 10mg, operating from Vapi, Gujarat, India—one of the country’s leading pharmaceutical manufacturing hubs.

With decades of formulation expertise, Taj Pharma adheres strictly to WHO-GMP manufacturing standards, ensuring that every tablet meets international pharmacopeial specifications. The company is recognized globally for consistent quality, regulatory transparency, and dependable export services.

Therapeutic Uses of Amitriptyline Hydrochloride Tablets 10mg

Amitriptyline Hydrochloride Tablets 10mg are used in the treatment and management of:

• Depression

• Anxiety disorders

• Neuropathic pain

• Migraine prophylaxis

• Insomnia

• Obsessive-compulsive disorder (OCD)

• Bed-wetting (enuresis)

• Chronic pain syndromes

It may take 4 to 6 weeks for Amitriptyline to demonstrate full therapeutic benefits. Due to its sedative nature, it is typically administered at bedtime. Patients should avoid activities requiring concentration until they understand how the medication affects them.

Safety advice:

• Avoid alcohol consumption

• Monitor body weight due to possible appetite increase

• Continue medication as prescribed for optimal results

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma ensures seamless product registration and market entry by providing complete regulatory support, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• Certificate of Analysis (COA)

• Method of Analysis (MOA)

• Stability Study Reports (ICH-compliant)

• CTD Dossier (Modules 1–5, as required)

• Product Specifications & Validation Documents

Custom Packaging & Labeling

• Alu-Alu and PVC blister packaging

• HDPE bottle packing

• Bulk packaging for institutional tenders

• Multilingual labels & artworks

• Private labeling for branded and generic markets

Shelf-Life, Storage & Dosage Form

• Dosage Form: Oral solid tablet

• Strength: 10mg

• Shelf-life: 24–36 months

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

Export Certifications

• WHO-GMP Certified Facility

• ISO Quality Management Systems

• GDP-compliant logistics

• Pharmacovigilance & post-marketing support

Target Countries & Export Markets

Taj Pharma exports Amitriptyline Hydrochloride Tablets 10mg to Asia, Africa, CIS, Latin America, and the Middle East, serving both regulated and semi-regulated markets.

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

State-of-the-Art Manufacturing

• Automated tablet compression and coating lines

• In-house quality control laboratories

• Stringent in-process and finished product testing

Affordable Pricing & Quality Assurance

• Competitive export pricing

• High API purity and formulation stability

• Batch-to-batch consistency

Global Presence & Supply Chain Support

• Robust export logistics network

• On-time delivery commitments

• Dedicated international business support team

Top 20 Countries Exporting

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 Table

Call to Action 

If you are searching for a Leading Amitriptyline Hydrochloride Tablets 10mg Manufacturer & Supplier in India, Taj Pharma is your ideal global partner. Contact us today for bulk supply, export inquiries, PCD Pharma Franchise opportunities, and customized packaging solutions.

Top 20 FAQs

1. What is Amitriptyline 10mg used for?
   Depression, neuropathic pain, insomnia, anxiety, and migraines.

2. Is Taj Pharma WHO-GMP certified?
   Yes, Taj Pharma operates WHO-GMP approved facilities.

3. Can Amitriptyline cause drowsiness?
   Yes, it has sedative effects.

4. When does Amitriptyline start working?
   Typically within 4–6 weeks.

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

6. Is custom packaging available?
   Yes, including private labeling.

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

8. Should alcohol be avoided?
   Yes, alcohol increases sedation.

9. Can weight gain occur?
   Yes, appetite may increase.

10. Is it safe for elderly patients?
    Often prescribed at low doses under supervision.

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

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

13. Is PCD Pharma Franchise offered?
    Yes.

14. Are stability studies conducted?
    Yes, per ICH guidelines.

15. Is bulk supply available?
    Yes.

16. Is it suitable for tenders?
    Yes, tender-ready documentation is available.

17. What dosage forms are supplied?
    Oral tablets.

18. Is pharmacovigilance support provided?
    Yes.

19. Can labeling be multilingual?
    Yes.

20. How can buyers contact Taj Pharma?
    Through the official sales and export team.