GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mirtazapine Tablet USP 7.5mg
B) Mirtazapine Tablet USP 15mg
C) Mirtazapine Tablet USP 30mg
D) Mirtazapine Tablet USP 45mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mirtazapine Tablet USP 7.5mg
Each film coated tablet contains:
Mirtazapine …………………………………..7.5mg
Excipients………………………………………..q.s.
Colour: Ferric Oxide of Red USP

B) Mirtazapine Tablet USP 15mg
Each film coated tablet contains:
Mirtazapine …………………………………..15mg
Excipients………………………………………..q.s.
Colour: Ferric Oxide of Yellow USP


C) Mirtazapine Tablet USP 30mg
Each film coated tablet contains:
Mirtazapine …………………………………..30mg
Excipients………………………………………..q.s
Colour: Ferric Oxide of Black USP

D) Mirtazapine Tablet USP 45mg
Each film coated tablet contains:
Mirtazapine …………………………………..45mg
Excipients………………………………………..q.s.
Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Mirtazapine is an antidepressant medicine. It's used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety. It works by increasing the amount of mood-enhancing chemicals called noradrenaline and serotonin in your brain. Mirtazapine is only available on prescription.

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).
Dosage: As directed by the Physician
Attach dispensing label as per end county.

Mirtazapine Tablet  15mg Technical Specification:

Product Name: Mirtazapine Tablet USP
Brand Name: Generic
Strength: 7.5mg, 15mg, 30mg, 45mg
Dosage Form: Tablets (Film coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 50s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-depressant
Indication: Mirtazapine is an antidepressant medicine. It’s used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety.
Storage: Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mirtazapine Tablet USP 7.5mg
  • Mirtazapine Tablet USP 15mg
  • Mirtazapine Tablet USP 30mg
  • Mirtazapine Tablet USP 45mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mirtazapine Tablet USP 7.5mg
    Each film coated tablet contains:
    Mirtazapine …………………………………..7.5mg
    Excipients………………………………………..q.s.
    Colour: Ferric Oxide of Red USP
  • Mirtazapine Tablet USP 15mg
    Each film coated tablet contains:

    Mirtazapine …………………………………..15mg
    Excipients………………………………………..q.s.
    Colour:Ferric Oxide of Yellow USP
  • Mirtazapine Tablet USP 30mg
    Each film coated tablet contains:
    Mirtazapine …………………………………..30mg
    Excipients………………………………………..q.s.
    Colour:Ferric Oxide of Black USP
  • Mirtazapine Tablet USP 45mg
    Each film coated tablet contains:
    Mirtazapine …………………………………..45mg
    Excipients………………………………………..q.s.
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

  • Mirtazapine is an antidepressant medicine. It’s used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety. It works by increasing the amount of mood-enhancing chemicals called noradrenaline and serotonin in your brain. Mirtazapine is only available on prescription.

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).
  • Dosage: As directed by the Physician

Attach dispensing label as per end county.

Introduction to Mirtazapine Tablet 15mg – Uses, Benefits & Rising Global Demand

What is Mirtazapine Tablet 15mg?

Mirtazapine Tablet 15mg is a prescription antidepressant used for:

  • Major depressive disorder (MDD)

  • Anxiety and panic disorders

  • Sleep disturbances caused by depression

  • Improving appetite and sleep in depressive individuals

  • Reducing persistent sadness, fatigue, and emotional imbalance

Taj Pharma ensures 100% purity, consistent potency, and compliance with global pharmacopoeias.

Why Global Demand is Rising?

  1. Increased awareness of depression as a treatable condition

  2. High efficacy with minimal dependency risk

  3. Affordable antidepressant therapy preferred by developing and developed nations

  4. Growing requirements from governments, tenders, hospitals, and distributors

Today, Taj Pharma’s Mirtazapine Tablet 15mg is exported to more than 48 countries, making it a dependable option for international buyers.


 Importers, Exporters & Global Buyers

Regulatory Documentation Provided by Taj Pharma

Taj Pharma provides complete regulatory support tailored for tenders, MOH submissions, and private distributors, including:

  • WHO-GMP Certificate

  • EU-GMP Compliance Documents (where required)

  • Certificate of Pharmaceutical Product (COPP)

  • Drug Master File (DMF) / CTD Dossier

  • Stability data (Zone II–IV)

  • COA, MOA, BMR, BPR

  • Free Sale Certificate (FSC)

  • GMP audit reports

This makes Taj Pharma the preferred partner for countries with strict regulatory frameworks.


Custom Packaging & Labeling Options

Taj Pharma offers private branding for global distributors:

  • Blister packs (Alu-Alu / PVC)

  • Bottled packaging

  • Cartooning with multilingual artwork

  • Tamper-proof, export-quality packaging

  • Custom foil printing with batch, MRP, and brand name


Shelf-Life, Storage & Dosage Form

  • Dosage Form: Film-coated Tablets

  • Strength: 15mg

  • Shelf-Life: 24–36 Months

  • Storage: Cool, dry place below 25°C

  • Pharmacopoeia Standards: IP / BP / USP (as required)


Export Certifications Ensuring Global Acceptance

Taj Pharma provides internationally accepted certifications:

  • WHO-GMP

  • EU-GMP (select facilities)

  • ISO 9001:2015

  • ISO 14001

  • COPP

  • cGMP compliance

  • CTD / ACTD dossiers

This makes Taj Pharma the most compliant Mirtazapine 15mg exporter from India.


Target Countries & Export Markets

Taj Pharma supplies Mirtazapine 15mg to over 48 countries, including:

  • Latin America: Peru, Chile, Colombia, Guatemala

  • Africa: Nigeria, Kenya, Tanzania, Ghana, Rwanda

  • Asia: Vietnam, Philippines, Sri Lanka, Afghanistan

  • CIS: Kazakhstan, Uzbekistan, Kyrgyzstan

  • Middle East: Iraq, Yemen, UAE, Kuwait

Its reputation for quality and affordability makes Taj Pharma the top choice for global importers.


 Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter of Mirtazapine Tablet 15mg

1. WHO-GMP & European-Standard Facilities

Taj Pharma operates state-of-the-art units in Vapi, Gujarat, equipped with:

  • Automated tablet compression lines

  • Advanced coating technology

  • In-house R&D

  • Microbiology & analytical testing labs

  • Zero-contamination manufacturing zones

This ensures unmatched quality and compliance.


2. Unbeatable Quality Assurance

Taj Pharma ensures:

  • USP/BP/IP compliance

  • Stability-tested batches

  • 21 CFR-compliant documentation

  • Rigorous in-process testing

  • Sterilized packaging lines

Every batch is tested for potency, dissolution, friability, safety, and purity.


3. Highly Competitive & Affordable Pricing

Taj Pharma offers direct factory pricing, making it ideal for:

  • Government tenders

  • Large-volume importers

  • Private label distributors

  • PCD franchise companies


4. Strong Global Presence & Distribution Network

Taj Pharma exports to 48+ countries with seamless logistics:

  • Sea shipments (FOB / CIF)

  • Air shipments

  • Door-to-door delivery (DDP for select countries)

  • Cold-chain support where required


Top 20 Countries Where  

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  

Parameter Details
Product Name Mirtazapine Tablet 15mg
Manufacturer Taj Pharma India
Strength 15mg
Therapeutic Class Tetracyclic Antidepressant
Composition Mirtazapine IP/BP/USP 15mg
Dosage Form Film-Coated Tablet
Indication Depression, Anxiety, Sleep Disorders
Packaging Alu-Alu / Blister / Bottle
Shelf-Life 24–36 months
Certifications WHO-GMP, ISO, COPP
Regulatory Dossier CTD / ACTD
Storage Store below 25°C
Manufacturer Location Vapi, Gujarat, India

Call to Action  

Looking for a reliable Mirtazapine Tablet 15mg Manufacturer & Supplier in India?

Taj Pharma guarantees:

  • Premium WHO-GMP quality

  • Best export pricing

  • Fastest delivery

  • OEM/private label support

  • 100% regulatory documentation

📞 Contact Taj Pharma Today
Email: info@tajpharma.com
Website: www.tajpharma.com


 Top 20 FAQs  

1. What is Mirtazapine 15mg used for?

It treats major depressive disorder, anxiety, and sleep disturbance.

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

Yes, Taj Pharma manufactures Mirtazapine 15mg in WHO-GMP compliant facilities.

3. Does Taj Pharma export Mirtazapine globally?

Yes, to 48+ countries across Africa, Asia, CIS, and Latin America.

4. What is the shelf-life of Mirtazapine 15mg?

24–36 months.

5. Can distributors request private label packaging?

Yes, full OEM branding and custom artwork are available.

6. What documents are provided for export?

COPP, COA, CTD dossier, stability data, FSC, and GMP certificates.

7. Is Mirtazapine 15mg safe?

Yes, when taken as prescribed by a doctor.

8. What are the side effects?

Dry mouth, sleepiness, dizziness, weight gain.

9. How does Mirtazapine work?

By increasing serotonin and noradrenaline in the brain.

10. Does Taj Pharma supply to government tenders?

Yes, Taj Pharma participates in international tenders.

11. What packing options are available?

Blister, Alu-Alu, bottle, multilingual cartons.

12. Does Taj Pharma offer samples?

Yes, depending on regulatory requirements.

13. Can Taj Pharma handle bulk orders?

Yes, production capacity supports large-volume demands.

14. Are batch-wise COA/MOA provided?

Yes, with each shipment.

15. Is Mirtazapine 15mg available for PCD franchise?

Yes, in PAN India franchise networks.

16. Can importers obtain CTD dossiers?

Yes, complete regulatory filing support is provided.

17. What countries import Mirtazapine from Taj Pharma?

Africa, Middle East, Asia, CIS, Latin America.

18. Does Taj Pharma offer competitive pricing?

Yes, being a direct manufacturer.

19. What is the minimum order quantity (MOQ)?

Varies by market; usually 100,000–300,000 tablets.

20. How can buyers contact Taj Pharma?

Via email at info@tajpharma.com or through the website.