GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Fluoxetine Capsules USP 20mg
C) Fluoxetine Capsules USP 40mg
D) Fluoxetine Capsules USP 60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….10mg
Excipients……………………………………. q.s.
Approved colour used in empty capsule shells.
B) Fluoxetine Capsules USP 20mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….20mg
Excipients…………………………………….q.s.
Approved colour used in empty capsule shells.
C) Fluoxetine Capsules USP 40mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….40mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.
D) Fluoxetine Capsules USP 60mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….60mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Dispense in tight and light resistant container.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end county.
Fluoxetine Capsules 20mg Technical Specification:
| Product Name: | Fluoxetine Capsules USP |
| Brand Name: | Generic |
| Strength: | 10mg, 20mg, 40mg, 60mg |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 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: | Antidepressants, Central nervous system |
| Indication: | Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Fluoxetine Capsules USP 10mg
B) Fluoxetine Capsules USP 20mg
C) Fluoxetine Capsules USP 40mg
D) Fluoxetine Capsules USP 60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Fluoxetine Capsules USP 10mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….10mg
Excipients……………………………………. q.s.
Approved colour used in empty capsule shells.
B) Fluoxetine Capsules USP 20mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….20mg
Excipients…………………………………….q.s.
Approved colour used in empty capsule shells.
C) Fluoxetine Capsules USP 40mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….40mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.
D) Fluoxetine Capsules USP 60mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….60mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.
THERAPEUTIC INDICATIONS:
Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder.
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 and light resistant container.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end county.
Introduction to Fluoxetine Capsules 20mg
Fluoxetine Capsules 20mg is a widely prescribed antidepressant belonging to the Selective Serotonin Reuptake Inhibitors (SSRIs) group of medicines. It is commonly used for the treatment of:
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Major Depressive Disorder (MDD)
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Obsessive-Compulsive Disorder (OCD)
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Panic Disorder
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Bulimia Nervosa (an eating disorder characterized by bingeing and purging)
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Anxiety-related disorders
By restoring serotonin balance in the brain, Fluoxetine Capsules 20mg improves mood, reduces anxiety, helps regulate sleep, increases energy levels, and enhances overall emotional stability.
The global demand for SSRIs such as Fluoxetine has been increasing due to the rising incidence of depression and mental health awareness. With more people worldwide seeking treatment, Fluoxetine Capsules 20mg has become a vital product in international pharmaceutical markets.
Taj Pharma, as a leading Fluoxetine Capsules 20mg manufacturer in India, ensures high-quality production in compliance with WHO-GMP and international standards. Their formulations are trusted by doctors, hospitals, distributors, and global buyers across multiple countries.
Fluoxetine Capsules 20mg for Importers, Exporters, and Global Buyers
For pharmaceutical buyers, regulatory approvals and documentation are crucial. Taj Pharma provides a comprehensive solution for international importers and distributors, ensuring smooth market entry and compliance with local regulatory authorities.
1. Regulatory Documentation Provided
Taj Pharma supports international buyers with a complete regulatory package, including:
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WHO-GMP Certificate
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EU-GMP Compliance Documents (for regulated markets)
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Certificate of Pharmaceutical Product (CoPP)
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CTD/ACTD Dossiers
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Stability and Bioequivalence Data
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Free Sale Certificate (FSC)
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ISO Certification
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Quality Assurance Reports
This documentation ensures hassle-free registration and regulatory approval in multiple countries.
2. Custom Packaging & Labeling
Taj Pharma provides:
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Custom branding and private labeling.
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Blister packs and alu-alu packaging.
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Market-specific labeling with multilingual support.
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Bulk and hospital packaging options.
3. Shelf-life, Storage & Dosage Form
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Dosage Form: Capsule (hard gelatin).
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Strength: Fluoxetine 20mg.
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Shelf-life: 24–36 months depending on storage.
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Storage: Store at room temperature, below 30°C, protected from moisture and sunlight.
4. Export Certifications
Taj Pharma’s Fluoxetine Capsules 20mg are manufactured under strict certifications:
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WHO-GMP approved facility.
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EU-GMP compliance for Europe.
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PIC/S GMP for advanced regulatory regions.
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ISO 9001:2015 Certification.
5. Target Countries & Export Markets
Taj Pharma exports Fluoxetine Capsules 20mg to over 50 countries worldwide, including:
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Africa: Nigeria, Ghana, Kenya, South Africa, Ethiopia.
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Asia: Vietnam, Philippines, Nepal, Sri Lanka, Cambodia.
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Middle East: UAE, Iraq, Yemen, Saudi Arabia.
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CIS: Uzbekistan, Kazakhstan, Russia, Ukraine.
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Latin America: Brazil, Chile, Peru, Bolivia, Ecuador.
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Europe: Poland, Romania, Germany (via EU-GMP).
Why is the Most Trusted Fluoxetine Capsules 20mg Manufacturer, Supplier, and Exporter
1. State-of-the-Art Manufacturing Facilities
Taj Pharma operates from its WHO-GMP and EU-GMP certified facility in Vapi, Gujarat, India.
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Advanced automated manufacturing systems.
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Strict quality assurance (QA) and quality control (QC) at each stage.
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International pharmacopoeial compliance (IP, BP, USP).
2. Affordable Pricing with Quality Assurance
Taj Pharma ensures affordable pricing without compromising quality. This makes them the preferred partner for:
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Global importers and distributors.
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PCD Pharma Franchise companies in India.
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Government tenders and hospital supply chains.
3. Global Presence & Supply Chain Strength
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Strong logistics support for timely delivery worldwide.
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Expertise in bulk supply, hospital tenders, NGO procurements, and private label partnerships.
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Recognized as a trusted partner in more than 50 international markets.
4. Top 20 Countries Exporting Fluoxetine Capsules 20mg
India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA
Technical Product Specification
| Product Name | Fluoxetine Capsules 20mg |
|---|---|
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
| Dosage Form | Hard Gelatin Capsule |
| Strength | Fluoxetine 20mg |
| Pharmacopoeia Standard | IP / BP / USP |
| Indications | Depression, OCD, Panic Disorder, Bulimia Nervosa |
| Packaging | 10×10 Capsules / Blister or Alu-Alu Packs |
| Storage | Store below 30°C in a dry, cool place |
| Shelf Life | 24–36 months |
| Certifications | WHO-GMP, EU-GMP, ISO, CoPP |
| Export Markets | Asia, Africa, CIS, Middle East, Latin America, Europe |
Fluoxetine Capsules 20mg PCD Pharma Franchise Opportunities
Taj Pharma also provides PCD Pharma Franchise opportunities across India for Fluoxetine Capsules 20mg. Franchise partners benefit from:
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Exclusive monopoly distribution rights.
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High-quality WHO-GMP products.
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Attractive marketing & promotional inputs.
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Lucrative margins and bulk supply support.
Top 20 FAQs
Q1: What are Fluoxetine Capsules 20mg used for?
A: They are used for depression, OCD, panic disorder, and bulimia nervosa.
Q2: Who is the leading Fluoxetine Capsules 20mg manufacturer in India?
A: Taj Pharma, based in Vapi, Gujarat.
Q3: How should Fluoxetine Capsules 20mg be taken?
A: As prescribed by a doctor, usually once daily at the same time.
Q4: What certifications does Taj Pharma provide for exports?
A: WHO-GMP, EU-GMP, CoPP, CTD Dossier, FSC, ISO.
Q5: What are the common side effects?
A: Nausea, fatigue, dry mouth, insomnia, loss of appetite.
Q6: Is Fluoxetine Capsules 20mg safe during pregnancy?
A: Consult your doctor before use.
Q7: What is the shelf life?
A: 24–36 months.
Q8: Does Taj Pharma offer custom branding?
A: Yes, private labeling and custom packaging are available.
Q9: Which countries import Fluoxetine 20mg from India?
A: More than 50 countries across Asia, Africa, CIS, Latin America, and Europe.
Q10: Can Fluoxetine cause sexual side effects?
A: Yes, decreased sexual drive or delayed ejaculation may occur.
Q11: Is Fluoxetine habit-forming?
A: No, but it should not be discontinued abruptly.
Q12: Does Taj Pharma offer PCD Pharma Franchise?
A: Yes, PAN India PCD opportunities are available.
Q13: Can children take Fluoxetine 20mg?
A: Only if prescribed by a pediatric psychiatrist.
Q14: What packaging options are available?
A: Blister packs, alu-alu strips, and hospital bulk packs.
Q15: How long does Fluoxetine take to show results?
A: 4–6 weeks for full therapeutic benefit.
Q16: What pharmacopoeial standards are followed?
A: IP, BP, USP.
Q17: Can Taj Pharma handle hospital tenders?
A: Yes, they are experienced in hospital and government tenders.
Q18: Does Taj Pharma export to EU markets?
A: Yes, via EU-GMP compliance.
Q19: Can Fluoxetine Capsules 20mg be purchased in bulk?
A: Yes, bulk orders are supported.
Q20: How to contact Taj Pharma for orders?
A: Buyers can contact Taj Pharma directly via their website or corporate office in Vapi, Gujarat.
If you are an importer, distributor, or pharma franchise partner looking for a reliable Fluoxetine Capsules 20mg manufacturer in India, Taj Pharma is your best choice. With WHO-GMP certified facilities, EU-GMP compliance, competitive pricing, and strong export expertise, Taj Pharma has built a reputation as a trusted pharmaceutical partner across the globe.






