Olanzapine and Fluoxetine Capsules 12mg+50mg

Olanzapine and Fluoxetine Capsules 12mg+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 12mg+50mg

Olanzapine and Fluoxetine Capsules 12mg+50mg is a fixed-dose combination medication used primarily to treat depressive episodes associated with Bipolar I Disorder and treatment-resistant depression (TRD) in adults.

This combination blends two active ingredients:

• Olanzapine – an atypical antipsychotic that helps rebalance dopamine and serotonin levels to improve mood and behavior.

• Fluoxetine – a selective serotonin reuptake inhibitor (SSRI) that enhances serotonin activity in the brain to combat depression and anxiety.

Together, they form a powerful therapy for individuals who do not respond adequately to standard antidepressant treatments.

Taj Pharma, the leading Olanzapine and Fluoxetine Capsules 12mg+50mg manufacturer in India, guarantees high-quality, WHO-GMP-compliant production. Each capsule is carefully formulated to ensure purity, consistency, and safety for patients worldwide.

This combination is not recommended for elderly patients with dementia or Alzheimer’s-related behavioral problems, as it may increase the risk of side effects.

With the global rise in bipolar disorder and depression, the demand for Olanzapine and Fluoxetine Capsules 12mg+50mg has seen significant growth across Asia, Africa, Latin America, and the Middle East.

2. In-Depth Details for Importers, Exporters, and Global Buyers

Taj Pharma, based in Vapi, Gujarat, India, is a trusted manufacturer, exporter, and supplier of Olanzapine and Fluoxetine Capsules 12mg+50mg with full regulatory documentation and support for international registration.

Regulatory Documentation Provided

Taj Pharma provides all essential documentation required for product registration and import approval globally:

• WHO-GMP Certificate

• EU-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Free Sale Certificate (FSC)

• CTD / ACTD Dossier

• Stability data & validation reports

• Batch Manufacturing Records (BMR)

These certifications assure importers and healthcare authorities of Taj Pharma’s global regulatory compliance.

Custom Packaging & Labeling

Taj Pharma offers customized export packaging to meet specific market and client requirements. Options include:

• Blister packs (Alu-Alu / PVC) – 10×10, 10×14, or 10×28

• HDPE Bottles – for bulk supplies and hospitals

• Private Labeling / OEM Manufacturing – for PCD partners and distributors worldwide

Every package maintains product integrity, moisture resistance, and global shipping durability.

Shelf-Life, Storage & Dosage Form

• Dosage Form: Hard Gelatin Capsule

• Composition: Olanzapine 12mg + Fluoxetine 50mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, in a dry, cool place away from sunlight

Export Certifications

Taj Pharma is a globally recognized WHO-GMP manufacturer with the following accreditations:

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

• EU-GMP (European Union – GMP)

• ISO 9001:2015 Certified

• COPP & FSC for international registrations

• CTD / ACTD dossier support

These certifications ensure that Olanzapine and Fluoxetine Capsules 12mg+50mg meet stringent international quality standards required for regulatory approvals in both regulated and semi-regulated markets.

Target Countries & Export Markets

Taj Pharma exports Olanzapine and Fluoxetine Capsules 12mg+50mg to over 50 countries globally.
Key export destinations include:

• Africa: Nigeria, Kenya, Ghana, Uganda, South Africa

• Asia: Sri Lanka, Bangladesh, Nepal, Vietnam, Philippines

• Middle East: UAE, Oman, Qatar, Saudi Arabia, Bahrain

• Europe: Russia, Belarus, Georgia, Kazakhstan, Turkey

• Latin America: Peru, Colombia, Ecuador, Bolivia, Chile

Each consignment is shipped with full quality documentation and temperature-controlled logistics, ensuring consistent product efficacy and stability during transit.

3. Why is the Most Trusted Manufacturer, Supplier, and Exporter

Taj Pharma stands among India’s top pharmaceutical manufacturers and exporters, known for ethical manufacturing practices, global reach, and regulatory excellence.

A. State-of-the-Art Manufacturing

Taj Pharma’s Vapi-based WHO-GMP-certified facility operates under strict quality assurance protocols, featuring:

• Automated tablet/capsule compression and coating lines

• Fully equipped quality control and microbiological labs

• Advanced HPLC and dissolution testing equipment

• In-house R&D division for formulation optimization

• Full compliance with Schedule M and ICH guidelines

This ensures consistent batch quality and high therapeutic efficacy of Olanzapine and Fluoxetine Capsules 12mg+50mg.

B. Affordable Pricing & Quality Assurance

Taj Pharma provides affordable, export-quality medicines without compromising on quality.
Key highlights include:

• Economical bulk pricing for importers and distributors

• Robust QA/QC systems for each production stage

• Validated manufacturing processes under cGMP norms

• WHO prequalification documentation support

Every capsule passes through multi-level quality checks, ensuring uniform potency, safety, and purity.

C. Global Presence & Supply Chain Support

With a strong logistics and regulatory network, Taj Pharma ensures:

• Timely global dispatches via air and sea freight

• Regulatory submission assistance for import approvals

• Customs and documentation support

• Efficient distribution through authorized global partners

The company’s strong export infrastructure and customer-centric services make it a preferred partner for pharmaceutical buyers and PCD distributors globally.

D. Top 20 Countries Exporting

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

4. Technical Product Specification Table

5. Call to Action  

Are you looking for a reliable WHO-GMP manufacturer and exporter of Olanzapine and Fluoxetine Capsules 12mg+50mg in India?
Partner with Taj Pharma, India’s #1 trusted pharmaceutical exporter, delivering affordable, high-quality psychiatric medications to over 50 countries.

Why Choose Taj Pharma?

• WHO-GMP & EU-GMP certified facilities

• Competitive pricing for global bulk orders

• Full regulatory documentation support

• PCD Pharma Franchise & contract manufacturing available

• On-time delivery across continents

📞 Contact Details: +91 74 0000 9975 
Taj Pharmaceuticals Ltd.
Plot No. 513, GIDC Industrial Estate, Vapi, Gujarat, India
🌐 Website: www.tajpharma.in
✉️ Email: info@tajpharma.com

6. Top 20 FAQs

1. What is Olanzapine and Fluoxetine Capsules 12mg+50mg used for?
It treats bipolar depression and treatment-resistant depression in adults.

2. Who manufactures these capsules in India?
Taj Pharma, a WHO-GMP-certified manufacturer based in Vapi, Gujarat, India.

3. Are the capsules export quality?
Yes. Taj Pharma produces export-grade capsules compliant with WHO and EU-GMP standards.

4. Can these capsules be used in elderly patients?
They are not recommended for behavioral issues in dementia or Alzheimer’s patients.

5. What are the side effects?
Common side effects include drowsiness, weight gain, dry mouth, blurred vision, and swelling.

6. How should the capsules be stored?
Store below 25°C, in a cool, dry place away from sunlight.

7. Can these capsules be taken with food?
Yes, they can be taken with or without food, as directed by a physician.

8. Are private labeling options available?
Yes, Taj Pharma provides private labeling and PCD franchise services.

9. What is the shelf life?
24 to 36 months, depending on storage conditions.

10. Is Taj Pharma a WHO-GMP certified manufacturer?
Yes, the facility fully complies with WHO-GMP and EU-GMP.

11. Can the capsules be exported worldwide?
Yes, Taj Pharma exports to more than 50 countries globally.

12. What packaging options are available?
Alu-Alu blister packs and HDPE bottles.

13. Does Taj Pharma assist with regulatory documentation?
Yes, full CTD / ACTD dossiers and COPPs are provided.

14. Are these capsules prescription-only?
Yes, use only under medical supervision.

15. Can Taj Pharma supply in bulk quantities?
Yes, bulk and institutional supply orders are accepted.

16. What class of drugs does Olanzapine belong to?
It’s an atypical antipsychotic.

17. What class of drugs does Fluoxetine belong to?
It’s a selective serotonin reuptake inhibitor (SSRI).

18. Can it cause drowsiness?
Yes, mild drowsiness and fatigue may occur initially.

19. What is the export process with Taj Pharma?
Taj Pharma manages end-to-end logistics, including export documentation and shipping.

20. How can buyers contact Taj Pharma?
Through www.tajpharma.in or via email at info@tajpharma.com.

Taj Pharma is the leading Olanzapine and Fluoxetine Capsules 12mg+50mg manufacturer in India, known for its WHO-GMP-certified production, affordable global supply, and unmatched quality standards.

Whether you are an importer, distributor, hospital, or PCD pharma franchise partner, Taj Pharma ensures you receive the best-quality, cost-effective, and compliant pharmaceutical formulations—trusted by healthcare professionals worldwide.