Olanzapine and Fluoxetine Capsules 6mg+25mg

Olanzapine and Fluoxetine Capsules 6mg+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 6mg+25mg

Olanzapine and Fluoxetine Capsules 6mg+25mg is a fixed-dose combination medication widely used in the management of depression associated with bipolar disorder and treatment-resistant depression (TRD) in adults. It combines two active agents: Olanzapine, an atypical antipsychotic, and Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), providing a synergistic approach to managing complex mood disorders.

Taj Pharma, the well-known Olanzapine and Fluoxetine Capsules 6mg+25mg manufacturer in India, gives the assurance of high-quality and purity. The formulation is not recommended for elderly patients with dementia or Alzheimer’s-related behavioral problems, maintaining patient safety and compliance with regulatory standards.

The global demand for this formulation continues to rise due to the growing prevalence of mood and depressive disorders. Taj Pharma meets this increasing demand by supplying WHO-GMP-certified products that conform to international quality and safety benchmarks.

2. Global Market Demand and Use

The Olanzapine and Fluoxetine Capsules 6mg+25mg combination is gaining importance globally for its dual-action efficacy in bipolar depression and major depressive disorder unresponsive to conventional therapies.

Countries in Asia-Pacific, Latin America, and Africa are witnessing a rapid increase in demand for affordable antidepressant medications. As such, Indian manufacturers like Taj Pharma have emerged as global leaders in supplying quality pharmaceutical formulations at cost-effective prices.

3. Product Overview and Medical Indications

• Brand Name: Olanzapine and Fluoxetine Capsules 6mg+25mg

• Active Ingredients: Olanzapine (6mg) + Fluoxetine (25mg)

• Dosage Form: Hard gelatin capsule

• Therapeutic Class: Antidepressant / Antipsychotic combination

• Indications:

  • Depressive episodes associated with Bipolar I Disorder

  • Treatment-resistant depression (TRD)

  • Major depressive disorder unresponsive to monotherapy antidepressants

Mechanism of Action

• Olanzapine helps restore neurotransmitter balance by acting on dopamine and serotonin receptors, reducing mood swings and stabilizing emotional fluctuations.

• Fluoxetine enhances serotonin levels in the brain, improving mood and reducing anxiety symptoms.

This combination allows physicians to target both psychotic and depressive symptoms effectively.

4. Manufacturing Excellence by Taj Pharma India

Taj Pharma – Commitment to Quality and Purity

Taj Pharma is a WHO-GMP-certified Olanzapine and Fluoxetine Capsules 6mg+25mg manufacturer in India, based in Vapi, Gujarat. The company ensures every capsule produced meets stringent international standards for potency, purity, and stability.

Their facilities adhere to EU-GMP, PIC/S, and ISO quality systems, ensuring consistency in every batch. Taj Pharma’s focus on R&D innovation and regulatory compliance distinguishes it as one of the most trusted pharmaceutical exporters from India.

Product Safety and Efficacy

Each batch undergoes multiple layers of in-process quality control, ensuring accurate dosage and patient safety. The company uses pharma-grade excipients and state-of-the-art analytical instruments to maintain uniformity and bioavailability.

5. Key Product Information for Buyers and Importers

Regulatory Documentation Provided

Taj Pharma supports international importers and regulatory agencies with a comprehensive set of documents, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF) / CTD Dossier

• COA (Certificate of Analysis)

• Stability Data (Real-time and Accelerated)

• Batch Manufacturing Records

Custom Packaging & Labeling

Customized packaging solutions are available to meet buyer and country-specific regulatory requirements. Packaging options include blister packs, bottles, and cartons, designed for maximum product protection and export durability.

Shelf-life and Storage

• Shelf-life: 24 to 36 months (depending on export market regulations)

• Storage: Store below 30°C in a dry place, protected from light and moisture

Dosage and Administration

The dose and duration are tailored according to individual patient needs and physician recommendations. The medication may be taken with or without food.

6. Export Certifications and Global Reach

Taj Pharma maintains international export certifications that make its products globally acceptable:

• WHO-GMP (World Health Organization – Good Manufacturing Practice)

• EU-GMP compliance for export to regulated markets

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier Support for registration

• ISO 9001:2015 Certified Manufacturing Units

Target Export Markets

Taj Pharma’s Olanzapine and Fluoxetine Capsules 6mg+25mg are successfully exported to over 50 countries, including:
Vietnam, Philippines, Nigeria, Kenya, Myanmar, Cambodia, Sri Lanka, Bangladesh, Peru, Ecuador, Bolivia, Ghana, Yemen, Iraq, Tanzania, Zambia, Ukraine, Venezuela, and South Africa.

7. Why Taj Pharma is the Most Trusted Manufacturer and Exporter

a. State-of-the-Art Manufacturing Infrastructure

Taj Pharma’s world-class facility in Vapi, Gujarat integrates advanced tablet and capsule manufacturing technology with automated systems ensuring uniformity and contamination-free production.

b. Affordable Pricing with Premium Quality

Taj Pharma’s pricing model ensures accessibility to cost-sensitive markets while upholding global quality benchmarks. The company is committed to producing affordable antidepressant formulations for global healthcare systems.

c. Regulatory Support and Documentation

With an expert regulatory affairs team, Taj Pharma provides end-to-end registration support to distributors and importers. All documentation complies with ICH and WHO standards.

d. Global Supply Chain and Distribution Network

Taj Pharma maintains a robust logistics and export network, ensuring timely delivery and continuous availability of pharmaceutical supplies globally.

e. Top 20 Export Countries

Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile

8. Technical Product Specification Table

9. Why Global Buyers Prefer Taj Pharma

• Trusted Brand: Recognized globally for quality and reliability.

• Full Regulatory Documentation: Ready dossiers for fast registration.

• Flexible MOQs: Ideal for small distributors or large-scale buyers.

• Responsive Customer Support: Dedicated export assistance team.

• Long-Term Partnership Focus: Sustainable business relationships with consistent supply assurance.

10. Call to Action for Buyers/Distributors

Are you looking for a reliable Olanzapine and Fluoxetine Capsules 6mg+25mg manufacturer, supplier, or exporter from India?
Partner with Taj Pharma Ltd, the global leader in psychiatric and antidepressant medications.

📞 Contact Taj Pharma Today:
🌐 Website: www.tajpharma.com
📧 Email:info@tajpharma.com
🏭 Headquarters: Taj Pharma Ltd., Vapi, Gujarat, India

11. Top 20 FAQs 

1. What is Olanzapine and Fluoxetine Capsules 6mg+25mg used for?
It treats depressive episodes in bipolar disorder and treatment-resistant depression.

2. Who manufactures Olanzapine and Fluoxetine Capsules 6mg+25mg in India?
Taj Pharma Ltd., a WHO-GMP certified manufacturer based in Vapi, Gujarat.

3. Is it safe for elderly patients?
Not recommended for dementia-related behavioral disorders in elderly patients.

4. What are the common side effects?
Drowsiness, weight gain, tremors, and dry mouth.

5. Can it be taken with food?
Yes, it can be taken with or without food as prescribed.

6. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, and EU-GMP compliance.

7. Is custom packaging available for exports?
Yes, Taj Pharma offers country-specific labeling and packaging.

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

9. How can importers register this product?
Through Taj Pharma’s complete CTD dossier and regulatory support.

10. What are the export markets for this product?
Asia, Africa, Latin America, and CIS countries.

11. What is the therapeutic class of this product?
Antidepressant / Antipsychotic combination.

12. Is Taj Pharma a WHO-GMP-certified company?
Yes, fully certified by WHO-GMP and ISO standards.

13. What are the dosage strengths available?
6mg+25mg and 12mg+50mg formulations.

14. Does Taj Pharma offer PCD Pharma Franchise opportunities?
Yes, PAN-India and international franchise options are available.

15. How to contact Taj Pharma for bulk orders?
Through their official website or export email listed above.

16. Is documentation support available for product registration?
Yes, Taj Pharma provides COA, COPP, and dossier support.

17. What packaging types are offered?
Blister, bottle, and carton packaging as per client requirements.

18. Does Taj Pharma export to regulated markets?
Yes, including Asia-Pacific, Africa, and Latin America.

19. Is Taj Pharma compliant with EU standards?
Yes, production meets EU-GMP guidelines.

20. Why choose Taj Pharma for this product?
Because of their unmatched quality, affordability, and international reputation.

Taj Pharma stands as the leading Olanzapine and Fluoxetine Capsules 6mg+25mg manufacturer in India, committed to delivering premium pharmaceutical solutions across the globe. With robust manufacturing infrastructure, international certifications, and proven product efficacy, Taj Pharma remains the preferred partner for importers, distributors, and PCD franchise owners worldwide.