Ketoconazole Tablets 200mg

Ketoconazole Tablets  200mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Ketoconazole Tablets IP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Ketoconazole Tablets IP 200mg
  Each uncoated tablet contains:
  Ketoconazole IP………………….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 & SCHEDULE:

CAUTION: Read enclosed leaflet before use.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

WARNING: 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 below 30°C.

Protect from Light and moisture.

Dosage: As directed by the Dermatologist/Gynaecologist

Introduction to Ketoconazole Tablets 200mg

Ketoconazole Tablets 200mg belong to a well-established class of medicines known as antifungals. These tablets are widely prescribed for treating a variety of fungal and yeast infections affecting the mouth, throat, vagina, skin, hair, and nails, including fingernails and toenails. Ketoconazole works by destroying the fungal cell membrane, thereby stopping fungal growth and eliminating the infection from the body.

With the rising prevalence of fungal infections worldwide—driven by climate conditions, immunocompromised populations, diabetes, and prolonged antibiotic use—the global demand for effective oral antifungal therapies continues to grow. This has significantly increased the Ketoconazole Tablets 200mg export from India, as Indian pharmaceutical manufacturers are recognized for quality, affordability, and regulatory compliance.

Taj Pharma, a well-known Ketoconazole Tablets 200mg Manufacturer in India, ensures high-quality production, purity, and therapeutic effectiveness. Manufactured at advanced facilities in Vapi, Gujarat, Taj Pharma’s Ketoconazole Tablets are trusted by healthcare providers, distributors, and importers across multiple international markets.

Therapeutic Uses, Mechanism of Action & Clinical Importance

Taj Pharma, the trusted Ketoconazole Tablets 200mg Supplier, produces this medicine strictly as per global pharmacopeial standards.

Key Uses

• Oral and esophageal candidiasis

• Vaginal yeast infections

• Systemic fungal infections

• Fungal infections of skin, hair, and nails

• Resistant fungal infections where topical therapy fails

How Ketoconazole Works

Ketoconazole inhibits the synthesis of ergosterol, a vital component of the fungal cell membrane. Without ergosterol, the fungal cell membrane becomes weak and leaky, leading to fungal cell death.

Dosage & Administration

• Must be taken with food to enhance absorption

• Tablets should be swallowed whole

• Dosage and treatment duration depend on infection type and severity

• Avoid antacids 1 hour before or 2 hours after taking the tablet

• Complete the full course even if symptoms improve early

Improper use or early discontinuation may lead to relapse or antifungal resistance, making patient compliance critical.

Side Effects, Warnings & Safety Information

Taj Pharma Ltd India, a recognized Ketoconazole Tablets 200mg Manufacturer & Supplier, ensures accurate labeling with complete safety guidance.

Common Side Effects

• Nausea and vomiting

• Abdominal pain

• Headache

• Diarrhea

• Itching or skin redness

• Increased liver enzymes

Serious Side Effects (Rare)

• Abnormal liver function

• Adrenal insufficiency

• Severe allergic reactions (rash, facial swelling, breathing difficulty)

Immediate medical attention is required if severe symptoms occur.

Precautions

• Not recommended during pregnancy unless clearly advised

• May be unsafe during breastfeeding

• Use cautiously in patients with liver disease, heart failure, or weakened immunity (including HIV/AIDS)

• Long-term therapy may require regular liver function tests

• Avoid driving if dizziness or blurred vision occurs

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

As a leading WHO-GMP Manufacturer India, Taj Pharma supports international buyers with complete regulatory dossiers:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP & ISO Certificates

• Certificate of Analysis (COA)

• Finished Product Specifications

• Stability Data

• CTD / eCTD Dossiers (on request)

Custom Packaging & Labeling

Taj Pharma offers flexible solutions for:

• Alu-Alu blister packs

• PVC blister packaging

• HDPE bottle packing

• Multilingual labels

• Private labeling & PCD Pharma Franchise support

Shelf Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 200mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, protect from light and moisture

Export Certifications

• WHO-GMP Certified

• ISO Quality Systems

• COPP / FSC Availability

• EU-GMP aligned processes (market-specific)

Target Countries & Export Markets

Taj Pharma exports Ketoconazole Tablets 200mg to:

• Africa

• Southeast Asia

• Middle East

• CIS Countries

• Latin America

• Caribbean Nations

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

State-of-the-Art Manufacturing

Taj Pharma’s facilities in Vapi, Gujarat operate under strict cGMP guidelines with:

• Automated production lines

• Dedicated quality control labs

• Validated processes & stability testing

Affordable Pricing with Assured Quality

As a Leading #1 Ketoconazole Tablets 200mg Manufacturer & Supplier in India, Taj Pharma delivers:

• Competitive export pricing

• Consistent batch-to-batch quality

• Compliance with global regulatory norms

Strong Global Presence & Supply Chain

Taj Pharma’s export-focused infrastructure ensures:

• Timely international deliveries

• End-to-end documentation support

• Long-term partnerships with distributors

Top 20 Countries Exported To

India , Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines, Cambodia, Nigeria, Kenya, Ghana, Egypt, Ethiopia, Morocco, Peru, Colombia, Ecuador, Bolivia , Ukraine, Uzbekistan, Kazakhstan

Technical Product Specification Table

Call to Action  

If you are looking for a reliable Ketoconazole Tablets 200mg Manufacturer in India, Taj Pharma is your trusted partner. We welcome importers, distributors, hospitals, and PCD Pharma Franchise partners to collaborate with us.

👉 Contact Taj Pharma today for bulk orders, samples, pricing, and regulatory documentation.

Top 20 FAQs  

1. What is Ketoconazole Tablets 200mg used for?
   Fungal and yeast infections.

2. Is Taj Pharma WHO-GMP certified?
   Yes.

3. Can Ketoconazole be taken with food?
   Yes, it should be taken with food.

4. What is the shelf life?
   24–36 months.

5. Is it safe during pregnancy?
   No, unless prescribed.

6. Can it affect the liver?
   Yes, monitoring is recommended.

7. Does Taj Pharma export globally?
   Yes, to over 20 countries.

8. Is private labeling available?
   Yes.

9. Is COPP available?
   Yes.

10. Can it be used for nail fungus?
    Yes, under medical advice.

11. Is it suitable for long-term use?
    Only under doctor supervision.

12. Can it cause dizziness?
    Yes, in some patients.

13. Is it prescription-only?
    Yes.

14. Is PCD Pharma Franchise available?
    Yes.

15. Where is Taj Pharma located?
    Vapi, Gujarat, India.

16. What packaging options are offered?
    Blister and bottle packs.

17. Can it interact with antacids?
    Yes, avoid close timing.

18. Does it work for resistant infections?
    Yes, when prescribed.

19. Is EU-GMP compliance available?
    Market-dependent.

20. How to place export orders?
    By contacting Taj Pharma’s export team.