Olanzapine and Fluoxetine Capsules 6mg+50mg

Olanzapine and Fluoxetine Capsules 6mg+50mg 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+50mg

Olanzapine and Fluoxetine Capsules 6mg+50mg is a fixed-dose combination medication used primarily in the treatment of depression associated with Bipolar I Disorder and Treatment-Resistant Depression (TRD) in adults. The combination harnesses the antipsychotic effects of Olanzapine and the antidepressant power of Fluoxetine, creating a synergistic effect to stabilize mood and relieve depressive symptoms in patients where standard antidepressants fail.

The global demand for Olanzapine and Fluoxetine Capsules 6mg+50mg has increased substantially due to the rising prevalence of bipolar disorder, major depressive disorder (MDD), and mental health awareness initiatives across countries. Exporters and pharmaceutical importers seek reliable, quality-assured suppliers who comply with international standards—and Taj Pharma stands at the forefront as the preferred Olanzapine and Fluoxetine Capsules 6mg+50mg manufacturer in India.

Taj Pharma, the well-known Olanzapine and Fluoxetine Capsules 6mg+50mg manufacturer in India, gives assurance of high-quality and purity. This medicine is not meant for behavioral problems related to dementia or Alzheimer’s disease in elderly patients. Taj Pharma ensures every batch adheres to strict regulatory norms, ensuring global buyers receive consistent therapeutic quality at competitive pricing.

Pharmacology and Clinical Use

The combination of Olanzapine (6mg), an atypical antipsychotic, and Fluoxetine (50mg), a selective serotonin reuptake inhibitor (SSRI), targets multiple neurotransmitters involved in mood regulation. This synergistic formulation:

• Balances serotonin and dopamine levels.

• Reduces depressive episodes in bipolar patients.

• Improves emotional stability.

• Helps patients resistant to single-drug antidepressant therapies.

Common side effects may include drowsiness, fatigue, increased appetite, weight gain, dry mouth, tremors, blurred vision, or swelling in hands and feet. Patients should be closely monitored by healthcare professionals for optimal dosing and minimal side effects.

Taj Pharma ensures each capsule delivers precise bioavailability and efficacy, backed by WHO-GMP and EU-GMP standards.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma supports all importers and global distributors by providing a complete documentation package for registration, tender participation, and market entry:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Stability Data (Accelerated & Long-Term)

• CTD/eCTD Dossier with all technical modules

• Bioequivalence and clinical data (where applicable)

Custom Packaging & Labeling

Taj Pharma provides fully customizable packaging and labeling according to the importing country’s regulatory requirements. Options include:

• Alu-Alu / Blister packs

• HDPE bottles

• Mono-cartons and shipper cartons with international barcoding

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

Shelf-life, Storage, and Dosage Form

• Dosage Form: Hard Gelatin Capsules

• Strength: 6mg Olanzapine + 50mg Fluoxetine

• Shelf Life: 24 to 36 months from the manufacturing date

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

Export Certifications

Taj Pharma’s manufacturing excellence is supported by multiple global certifications and accreditations:

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

• EU-GMP Compliance

• COPP (Certificate of Pharmaceutical Product)

• ISO 9001:2015 Certified Quality Systems

• CTD Dossier Format Compliance

• Approved by FDA and Health Authorities of various countries

Target Countries & Export Markets

Taj Pharma exports Olanzapine and Fluoxetine Capsules 6mg+50mg to more than 80 countries across Asia, Africa, Latin America, CIS, and the Middle East.

Key Export Markets Include:

• Nigeria

• Kenya

• Philippines

• Vietnam

• Myanmar

• Cambodia

• Sri Lanka

• Ghana

• Uganda

• Zambia

• South Africa

• UAE

• Oman

• Yemen

• Iraq

• Peru

• Bolivia

• Guatemala

• Honduras

• Dominican Republic

Taj Pharma also supports PCD Pharma Franchise operations PAN India, enabling local entrepreneurs and distributors to market quality psychotropic medications under their own brand names.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

Located in Vapi, Gujarat, Taj Pharma operates one of India’s most modern pharmaceutical manufacturing facilities. The site complies with WHO-GMP, EU-GMP, and cGMP standards, ensuring every product batch meets the highest international quality benchmarks. Automated systems, quality audits, and validated processes ensure consistency and compliance.

2. Affordable Pricing with Quality Assurance

Taj Pharma prioritizes cost-efficiency without compromising quality. By optimizing production, sourcing high-quality APIs, and maintaining lean manufacturing processes, Taj Pharma offers competitive export pricing while adhering to stringent pharmacovigilance and safety standards.

3. Global Presence & Supply Chain Strength

With an established global distribution network, Taj Pharma has built long-term relationships with importers, government institutions, hospitals, and wholesalers. Its advanced logistics ensure timely delivery of products across continents, backed by professional documentation and regulatory support.

4. Certifications and Recognitions

Taj Pharma’s excellence is reflected through:

• Approval from various Drug Control Authorities

• Multiple ISO and GMP certifications

• Recognition as a leading exporter by Pharmexcil (India)

• Regular participation in global pharma exhibitions

5. Top 20 Export Countries

Taj Pharma’s reliability and customer satisfaction make it a top-tier partner for global buyers seeking Olanzapine and Fluoxetine Capsules 6mg+50mg export from India.

Technical Product Specification Table

Call to Action 

If you are an importer, distributor, or pharmaceutical company looking for a trusted partner to supply Olanzapine and Fluoxetine Capsules 6mg+50mg, Taj Pharma is your ideal choice.

✅ WHO-GMP & EU-GMP Certified Manufacturing
✅ Full Regulatory Dossier Support
✅ Global Export Experience in 80+ Countries
✅ Flexible Private Label & PCD Franchise Options
✅ Competitive Pricing with Guaranteed Quality

📞 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 6mg+50mg used for?
It is prescribed for bipolar depression and treatment-resistant depression in adults.

2. Can it be used for Alzheimer’s or dementia-related depression?
No, it is not recommended for elderly patients with dementia-related psychosis.

3. What certifications does Taj Pharma have?
Taj Pharma is WHO-GMP, EU-GMP, and ISO-certified, ensuring top-quality pharmaceutical production.

4. Can importers request customized packaging?
Yes, packaging and labeling can be customized per regulatory and branding requirements.

5. What is the shelf life of this formulation?
Typically 24 to 36 months from the manufacturing date.

6. Is the product bioequivalent to innovator brands?
Yes, Taj Pharma provides BE (Bioequivalence) documentation upon request.

7. How should this medicine be stored?
Store below 30°C, away from moisture and sunlight.

8. Are CTD dossiers available?
Yes, complete CTD/eCTD dossiers are available for registration purposes.

9. Does Taj Pharma provide export assistance?
Yes, including COA, COPP, and stability data.

10. Is private labeling possible?
Yes, Taj Pharma supports private-label partnerships globally.

11. What dosage form is available?
Hard gelatin capsules.

12. Does Taj Pharma supply PCD Pharma Franchise in India?
Yes, across PAN India regions.

13. What is the minimum order quantity (MOQ)?
Negotiable depending on destination and regulatory needs.

14. Are there side effects?
Possible side effects include drowsiness, weight gain, and dry mouth.

15. Can it be exported to Africa and Asia?
Yes, Taj Pharma exports to over 80 countries worldwide.

16. What documentation is provided for export registration?
COPP, COA, CTD dossier, and GMP certificates.

17. Are WHO prequalified products available?
Yes, for specific categories.

18. Is it suitable for long-term therapy?
Yes, under doctor supervision.

19. Why choose Taj Pharma over competitors?
Superior quality, global recognition, affordability, and regulatory expertise.

20. How can I contact Taj Pharma?
Visit www.tajpharma.in or email info@tajpharma.com.

When it comes to sourcing Olanzapine and Fluoxetine Capsules 6mg+50mg manufacturer in India, Taj Pharma stands as a global leader offering unparalleled quality, reliability, and regulatory excellence. With world-class manufacturing infrastructure, stringent quality controls, and proven export experience, Taj Pharma remains the top choice for pharmaceutical importers, PCD franchise partners, and global distributors seeking a trusted WHO-GMP-certified partner.