Olanzapine and Fluoxetine Capsules 3mg+25mg

Olanzapine and Fluoxetine Capsules 3mg+25mg Technical Specification: 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Olanzapine and Fluoxetine Capsules USP 3mg+25mg
B) Olanzapine and Fluoxetine Capsules USP 6mg+25mg
C) Olanzapine and Fluoxetine Capsules USP 6mg+50mg
D) Olanzapine and Fluoxetine Capsules USP 12mg+50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Olanzapine and Fluoxetine Capsules USP 3mg+25mg
Each hard gelatin Capsule contains:
Olanzapine USP…………………………………3mg
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine Base…………….25mg
Excipients……………………………………………q.s
Approved colours used in empty capsule shells.

B) Olanzapine and Fluoxetine Capsules USP 6mg+25mg
Each hard gelatin Capsule contains:
Olanzapine USP…………………………………….6mg
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine Base………………25mg
Excipients…………………………………………….q.s
Approved colours used in empty capsule shells.

C) Olanzapine and Fluoxetine Capsules USP 6mg+50mg
Each hard gelatin Capsule contains:
Olanzapine USP………………………………………6mg
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine Base……………….50mg
Excipients……………………………………………….q.s
Approved colours used in empty capsule shells.

D) Olanzapine and Fluoxetine Capsules USP 12mg+50mg
Each hard gelatin Capsule contains:
Olanzapine USP………………………………………12mg
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine Base………………….50mg
Excipients…………………………………………………q.s
Approved colours used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Olanzapine and Fluoxetine are combination of 2 drugs, olanzapine (an antipsychotic drug) and fluoxetine (a selective serotonin reuptake inhibitor-SSRI). It is used to treat a certain type of mental/mood disorder (depression associated with bipolar disorder). It is also used to treat depression that has not responded to other medications. This medication may help you sleep, improve your mood, improve your concentration, and decrease nervousness. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

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 psychiatrist only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the psychiatrist.

Introduction to Olanzapine and Fluoxetine Capsules 3mg+25mg

Olanzapine and Fluoxetine Capsules 3mg+25mg is a combination antidepressant and antipsychotic medication prescribed to manage depressive episodes associated with Bipolar I Disorder and Treatment-Resistant Depression (TRD). The formulation synergizes Olanzapine, an atypical antipsychotic, and Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), to provide enhanced efficacy in treating mood disorders where single-drug therapy has failed.

Taj Pharma, the well-known Olanzapine and Fluoxetine Capsules 3mg+25mg manufacturer in India, gives assurance of high-quality and purity. This combination is used to treat depression that occurs as part of bipolar disorder, and depression in patients who have not responded well to other antidepressants. However, it should not be used to manage behavioral problems in elderly patients with dementia or Alzheimer’s disease.

With mental health awareness rising globally and increasing cases of resistant depression, the demand for Olanzapine and Fluoxetine Capsules 3mg+25mg has surged across Asia, Africa, Latin America, and the Middle East. Taj Pharma, from Vapi, Gujarat, India, has emerged as a global leader in psychiatric formulation exports, known for quality consistency, regulatory compliance, and customer trust.

Pharmacological Overview and Clinical Significance

This medication combines two effective psychiatric agents:

• Olanzapine (3mg): An atypical antipsychotic that balances dopamine and serotonin activity in the brain.

• Fluoxetine (25mg): An SSRI that increases serotonin levels to improve mood and reduce anxiety.

Together, these components target both psychotic and depressive symptoms, offering a comprehensive treatment approach.

Therapeutic Indications:

• Depressive episodes linked to Bipolar I Disorder (“low” mood phase)

• Treatment-Resistant Depression (TRD) in adults

• Major Depressive Disorder (MDD) unresponsive to monotherapy

Common side effects include drowsiness, increased appetite, weight gain, dry mouth, tremor, blurred vision, and mild swelling in extremities. Taj Pharma’s high-purity formulation minimizes adverse effects through optimized bioavailability and stable capsule integrity.

In-depth Details for Importers, Exporters, and Buyers

As a globally recognized pharmaceutical exporter, Taj Pharma supports clients with complete technical and regulatory documentation to ease market registrations and import licensing.

Regulatory Documentation Provided

Taj Pharma provides an exhaustive dossier and regulatory support package, including:

• WHO-GMP and COPP Certificates

• Certificate of Analysis (COA)

• Product Specifications and Method of Analysis

• CTD/eCTD Dossier (Modules 1–5)

• Stability Data (Real-Time and Accelerated)

• Free Sale Certificate and Manufacturing License

Custom Packaging and Labeling

Taj Pharma provides customized packaging solutions based on buyer and country-specific regulations:

• Alu-Alu or Blister Packs for moisture protection

• HDPE bottles for bulk packaging

• Multilingual labeling (English, French, Arabic, Spanish, Russian, etc.)

• Private labeling for PCD Pharma Franchise partners

Shelf-life, Storage, and Dosage Form

• Dosage Form: Hard Gelatin Capsule

• Strength: 3mg Olanzapine + 25mg Fluoxetine

• Shelf Life: 24–36 months from manufacturing date

• Storage: Store below 30°C, protect from light and moisture

Export Certifications

Taj Pharma’s facilities and products are backed by international certifications and accreditations:

• WHO-GMP Certified by Indian FDA

• EU-GMP Compliance for regulated markets

• ISO 9001:2015 Certification for Quality Management Systems

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier Support for Registrations

• FDA & Ministry of Health Approvals from several countries

Target Countries and Export Markets

Taj Pharma exports to over 80 countries, making it a preferred choice for Olanzapine and Fluoxetine Capsules 3mg+25mg export from India.

Major Export Destinations Include:

• Philippines

• Vietnam

• Kenya

• Nigeria

• South Africa

• Sri Lanka

• Myanmar

• Cambodia

• Ghana

• Uganda

• UAE

• Oman

• Iraq

• Yemen

• Bolivia

• Guatemala

• Peru

• Dominican Republic

• Honduras

• Panama

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

1. Advanced Manufacturing Facilities

Taj Pharma operates state-of-the-art WHO-GMP-certified facilities in Vapi, Gujarat, India, equipped with advanced production and quality control systems. Automated manufacturing lines ensure consistent batch quality, validated processes, and compliance with global regulatory standards.

2. Unmatched Quality and Affordability

As a vertically integrated manufacturer, Taj Pharma uses high-quality Active Pharmaceutical Ingredients (APIs) and stringent in-process quality checks. Despite its superior manufacturing standards, Taj Pharma maintains competitive export pricing, making it the preferred choice for importers seeking affordability with reliability.

3. Global Presence and Supply Chain Expertise

With a strong logistics backbone, Taj Pharma guarantees timely international deliveries and customized documentation. Its export department assists buyers in meeting country-specific registration norms, ensuring seamless import approvals and tenders.

4. Commitment to Regulatory Excellence

Taj Pharma’s in-house regulatory affairs team specializes in dossier preparation and coordination with foreign health authorities, ensuring clients receive ready-to-file documentation packages with full technical support.

5. Top 20 Export Countries

Taj Pharma’s consistent commitment to excellence and compliance has earned it the reputation of being one of the leading exporters of Olanzapine and Fluoxetine Capsules 3mg+25mg from India.

Technical Product Specification Table

Taj Pharma’s PAN India and Global Reach

Taj Pharma has established itself as a pioneer exporter and PCD franchise provider for psychiatric medicines across PAN India. Its formulations are distributed under multiple brand names through a network of franchise partners in Mumbai, Delhi, Chennai, Hyderabad, Bangalore, and Ahmedabad, as well as in global markets.

Whether you are a government tender buyer, private label company, or pharmaceutical importer, Taj Pharma ensures you get consistent access to WHO-GMP-certified Olanzapine and Fluoxetine Capsules 3mg+25mg.

If you are looking for a reliable Olanzapine and Fluoxetine Capsules 3mg+25mg manufacturer, supplier, or exporter in India, Taj Pharma is your trusted partner for quality, compliance, and affordability.

✅ WHO-GMP & EU-GMP Certified Production
✅ Complete Dossier & Regulatory Support
✅ Flexible Private Label and Franchise Options
✅ 80+ Global Export Markets
✅ Affordable, High-Quality Formulations

📞 Contact Taj Pharma Today:
Website: www.tajpharma.in
Email: info@tajpharma.com
Phone: +91 84484 44095 (Gen. Enq. 01)
Address: Taj Pharma India Ltd., Vapi, Gujarat, India

Top 20 FAQs

1. What is Olanzapine and Fluoxetine Capsules 3mg+25mg used for?
It treats depressive episodes in bipolar disorder and treatment-resistant depression.

2. Can elderly patients with dementia take this medication?
No, it is not recommended for patients with dementia-related psychosis.

3. What is the mechanism of action?
It balances dopamine and serotonin levels to stabilize mood and improve depressive symptoms.

4. Does Taj Pharma provide WHO-GMP certification?
Yes, all Taj Pharma products, including this formulation, are WHO-GMP-certified.

5. Is private labeling available?
Yes, Taj Pharma provides private label services for distributors and franchise partners.

6. What dosage forms are offered?
Hard gelatin capsules containing Olanzapine 3mg + Fluoxetine 25mg.

7. What is the shelf life?
Typically 24 to 36 months from manufacturing date.

8. Can it be exported globally?
Yes, Taj Pharma exports to 80+ countries across all continents.

9. What documentation is provided?
COA, COPP, CTD Dossier, Stability Data, and Manufacturing License.

10. Are BE (Bioequivalence) studies available?
Yes, BE data can be shared upon request for registration purposes.

11. Does Taj Pharma have PCD Pharma Franchise opportunities?
Yes, PAN India PCD and distribution opportunities are available.

12. Are customized packaging options available?
Yes, customized branding and multilingual labeling are offered.

13. Are there common side effects?
Drowsiness, dry mouth, weight gain, and blurred vision may occur.

14. How should this medicine be stored?
Below 30°C, away from sunlight and moisture.

15. What is the minimum order quantity for export?
Flexible, depending on market and regulatory requirements.

16. Are CTD dossiers available for registration?
Yes, full technical dossiers are ready for submission.

17. How is Taj Pharma’s quality verified?
Through WHO-GMP audits and in-house QA/QC systems.

18. Is the formulation cost-effective?
Yes, Taj Pharma offers globally competitive export pricing.

19. What therapeutic category does this belong to?
Antidepressant/antipsychotic combination.

20. How can importers contact Taj Pharma?
Via www.tajpharma.in or info@tajpharma.com.

In the rapidly growing global market for psychiatric medications, Taj Pharma stands tall as the #1 Olanzapine and Fluoxetine Capsules 3mg+25mg manufacturer in India. With WHO-GMP-certified infrastructure, regulatory excellence, and a commitment to affordable healthcare, Taj Pharma continues to lead as the most trusted exporter and supplier for global buyers seeking high-quality pharmaceutical formulations.