GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Ketoconazole USP 200mg
Excipients q.s
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 Registered Medical Practitioner only.
Ketoconazole has been associated with hepatic toxicity including some fatalities. Patient receiving this drug should be informed of the risk and should be closely monitored.
STORAGE & DOSAGE:
Protect from light and moisture.
Dosage: As directed by the Dermatologist/Gynaecologist
Attach dispensing label as per end county.
Ketoconazole Tablets 200mg Technical Specification:
| Product Name: | Ketoconazole Tablets USP |
| Brand Name: | Generic |
| Strength: | 200mg |
| Dosage Form: | Tablets (Uncoated) |
| 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: | Antifungal |
| Indication: | Ketoconazole is an antifungal medicine. It’s used to treat skin infections caused by a fungus (yeast). It can also prevent them coming back. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Ketoconazole Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Ketoconazole Tablets USP 200mg
Each uncoated tablet contains:
Ketoconazole USP 200mg
Excipients q.s
THERAPEUTIC INDICATIONS:
Ketoconazole is used to treat skin infections such as athlete’s foot, jock itch, ringworm, and certain kinds of dandruff. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Ketoconazole is an azole antifungal that works by preventing the growth of fungus.
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 Registered Medical Practitioner only.
Ketoconazole has been associated with hepatic toxicity including some fatalities. Patient receiving this drug should be informed of the risk and should be closely monitored.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Dermatologist/Gynaecologist
Attach dispensing label as per end county.
Introduction to Ketoconazole Tablets 200mg
Ketoconazole Tablets 200mg are a potent antifungal medication widely prescribed for treating serious fungal and yeast infections. This includes conditions such as candidiasis (thrush), blastomycosis (Gilchrist’s disease), coccidioidomycosis (Valley fever), histoplasmosis (Darling’s disease), chromoblastomycosis, and paracoccidioidomycosis. Ketoconazole works by inhibiting fungal cell membrane synthesis, effectively killing the fungi and preventing their spread throughout the body.
Globally, the demand for antifungal agents like Ketoconazole Tablets 200mg has increased due to the rise in immunocompromised populations, prevalence of chronic illnesses, and fungal infections in both hospitals and community settings. It is also commonly used for treating infections of the mouth, throat, vagina, fingernails, and toenails, making it an essential medicine in pharmaceutical markets worldwide.
Trusted Ketoconazole Tablets 200mg Manufacturer in India
Taj Pharma, the renowned Ketoconazole Tablets 200mg manufacturer in India, guarantees high-quality, pure, and effective medications. Produced under strict WHO-GMP certified facilities, Taj Pharma ensures every batch meets international pharmaceutical standards, making it a reliable choice for global distributors and healthcare providers.
Taj Pharma’s commitment to quality assurance, safety, and regulatory compliance has earned it a reputation as a leading manufacturer, supplier, and exporter of Ketoconazole Tablets 200mg.
Manufacturer, Exporter & Supplier from Vapi, Gujarat
Taj Pharma Ltd India is recognized as a top Manufacturer, Exporter, and Supplier of Ketoconazole Tablets 200mg from Vapi, Gujarat. These tablets belong to the antifungal class of medicines, effectively targeting fungal infections by destroying the fungal cell membrane.
Patients are advised to take the tablets with food, swallow them whole, and follow the prescribed dosage and treatment duration. It is crucial to complete the full course, even if symptoms improve early, to prevent recurrence or resistance. Avoid antacids within one hour before or two hours after administration, as they may reduce drug absorption.
Clinical Use and Safety Information
As a leading Ketoconazole Tablets 200mg Manufacturer & Supplier in India, Taj Pharma emphasizes safe usage:
Common side effects include:
-
Stomach pain
-
Headache
-
Nausea
-
Abnormal liver function
Severe allergic reactions are rare but require immediate medical attention. These include:
-
Rash
-
Swelling of lips, throat, or face
-
Difficulty breathing
-
Dizziness or fainting
Patients are advised to consult a healthcare professional for persistent or severe side effects.
Administration Guidelines
-
Dosage Form: Tablet
-
Strength: 200mg
-
Administration: Oral, with food
-
Treatment Duration: As prescribed by a doctor
-
Dosage Advice: Take evenly spaced doses to maintain effective drug levels
Following these guidelines ensures optimal therapeutic outcomes and minimizes risks of resistance or recurrence.
PAN India Manufacturer & Supplier
Taj Pharma is widely recognized as a reliable Ketoconazole Tablets 200mg Manufacturer, Supplier, and Exporter. Their offerings include:
-
PAN India Manufacturing and Supply
-
PCD Pharma Franchise Opportunities
-
Bulk supply to hospitals and distributors
-
Competitive pricing with export-ready packaging
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma ensures smooth international trade with complete regulatory documentation:
-
WHO-GMP Certification
-
Certificate of Pharmaceutical Product (COPP)
-
Free Sale Certificate (FSC)
-
Certificate of Analysis (CoA)
-
Stability Reports
-
CTD Dossier
These documents facilitate global compliance and smooth customs clearance.
Custom Packaging & Labeling
Taj Pharma provides flexible packaging solutions:
-
Alu-Alu blister packs
-
Alu-PVC blister packs
-
HDPE bottles
-
Private labeling options
-
Bulk export packs
All packaging ensures safety, product integrity, and shelf-life preservation.
Shelf-Life, Storage & Dosage Form
-
Dosage Form: Tablet
-
Strength: 200mg
-
Shelf Life: 24–36 months
-
Storage: Store below 25°C in a dry place, away from sunlight
Export Certifications & Quality Standards
Taj Pharma adheres to international quality standards:
-
WHO-GMP certified production
-
ISO-certified facilities
-
Batch-to-batch consistency
-
Advanced quality control testing
Target Countries & Export Markets
Taj Pharma exports Ketoconazole Tablets 200mg from India to multiple countries:
-
Middle East: UAE, Saudi Arabia, Oman
-
Africa: Nigeria, Kenya, South Africa
-
Southeast Asia: Philippines, Vietnam, Myanmar
-
CIS Countries: Kazakhstan, Uzbekistan
-
Latin America: Peru, Bolivia
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
State-of-the-Art Manufacturing Facilities
-
Automated tablet compression lines
-
Controlled cleanroom environments
-
Advanced coating and packaging units
-
Stringent quality control measures
Affordable Pricing with Global Quality Assurance
-
Competitive pricing for domestic and international buyers
-
Adherence to USP, BP, and IP standards
-
Full regulatory compliance and documentation
Global Presence & Reliable Supply Chain
-
Timely worldwide shipments
-
Flexible order quantities
-
End-to-end export documentation support
-
Dedicated international sales team
Top 20 Countries Taj Pharma Exports To
USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia
Technical Product Specification Table
| Parameter | Details |
|---|---|
| Product Name | Ketoconazole Tablets |
| Strength | 200mg |
| Dosage Form | Tablet |
| Therapeutic Class | Antifungal |
| Indications | Fungal and Yeast Infections |
| Shelf Life | 24–36 Months |
| Storage | Below 25°C, dry place |
| Packaging | Blister / HDPE Bottle |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat |
| Certifications | WHO-GMP, ISO |
PCD Pharma Franchise Opportunities
Taj Pharma offers PCD Pharma Franchise opportunities for Ketoconazole Tablets 200mg, including:
-
Monopoly rights in assigned territories
-
Competitive profit margins
-
Marketing and promotional support
-
Timely product supply
Top 20 FAQs
-
What is Ketoconazole 200mg used for?
Treats serious fungal infections. -
Who manufactures it in India?
Taj Pharma Ltd. -
Is it WHO-GMP certified?
Yes. -
How should it be taken?
With food, as prescribed. -
Common side effects?
Stomach pain, nausea, headache, liver function abnormalities. -
Severe allergic reactions?
Rash, swelling, breathing problems – seek emergency help. -
Shelf life?
24–36 months. -
Available for bulk export?
Yes. -
Can it be private labeled?
Yes. -
Storage conditions?
Below 25°C, dry place. -
Target export countries?
Middle East, Africa, Southeast Asia, Latin America. -
Prescription required?
Yes. -
Suitable for elderly?
Yes, under medical supervision. -
Pregnancy and breastfeeding?
Consult physician. -
Drug interactions?
Avoid antacids within one hour before or two hours after. -
How long to see results?
Depends on infection type; follow full course. -
Are PCD opportunities available?
Yes. -
Pharmacovigilance supported?
Yes. -
How to place international orders?
Contact Taj Pharma sales team. -
Why choose Taj Pharma?
Quality, compliance, global presence, and affordability.






