Composition: Ketoconazole IP 200 mg / Ketoconazole USP 200 mg (separate labeled variants)
Usage: Restricted specialist treatment of certain serious fungal infections, where authorized
Category: Antifungal drugs
Therapeutic category: Antifungal
SKU: Ketoconazole Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Ketoconazole Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Healthy Life Pharma Pvt. Ltd. presents Ketoconazole 200 mg oral tablets for regulated pharmaceutical supply. Ketoconazole is an imidazole antifungal; oral use is severely restricted in many countries because it can cause life-threatening liver injury, adrenal suppression, and serious drug interactions. It should be considered only where locally authorized and when safer effective alternatives are unavailable or not tolerated.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification claimed; verify current certificate). Exporter: Healthy Inc (Star Export House status subject to verification). Contract manufacturing and export availability are subject to local product authorization.
| Product name | Ketoconazole Tablets |
|---|---|
| Composition | Ketoconazole IP 200 mg or Ketoconazole USP 200 mg, as stated on the respective product label |
| Dosage form | Uncoated oral tablet |
| CAS | 65277-42-1 |
| Therapeutic class | Systemic azole antifungal (restricted oral use) |
| Pharmacopoeial grade | IP / USP as applicable to individual SKU; compliance requires batch testing |
| Shelf life / packaging | As approved on individual product label; 36 months and blister configurations require confirmation |
| SKU | Ketoconazole Tablets |
Oral ketoconazole has pH-dependent solubility; formulation design and dissolution testing are important. Manufacturing controls may include validated blending, compression, impurity control, and appropriate packaging. Specific equipment, excipients, and dissolution performance must be verified against the approved master formula and batch records. Reduced stomach acidity may impair absorption and cannot be assumed to be corrected by tablet formulation alone.
Relevant release testing includes identification, assay, content uniformity, dissolution, related substances, and stability testing against the applicable approved specification. Numerical acceptance criteria must follow the applicable pharmacopoeial monograph and approved dossier rather than an assumed universal 90–110% range. Certificates of Analysis should be batch-specific.
Ketoconazole inhibits fungal ergosterol synthesis by inhibiting lanosterol 14-alpha-demethylase. Oral ketoconazole may be considered for selected serious fungal infections only where authorized, when other effective antifungals are unavailable or not tolerated, and after specialist assessment. It is not indicated for routine skin, nail, or Candida infections in jurisdictions such as the United States. Some jurisdictions have separate specialist regulatory pathways for ketoconazole in endogenous Cushing’s syndrome; this is not an interchangeable indication for every 200 mg tablet product.
Product registration and export may require a CTD/ACTD dossier, GMP evidence, Certificate of Analysis, and other country-specific documentation. Availability of a COPP, Free Sale Certificate, and specific destination-market authorization should be verified before making regulatory or supply commitments.
Q: What strengths are listed? A: Ketoconazole 200 mg in IP and USP versions.
Q: Is oral ketoconazole suitable for ordinary skin or nail fungus? A: No; its oral use is restricted because safer options are usually available.
Q: Why are liver tests needed? A: Severe and sometimes fatal liver injury can occur even without pre-existing liver disease.
Q: Does it interact with acid-reducing medicines? A: Yes, medicines that reduce stomach acidity can lower ketoconazole absorption. Ask the prescribing specialist or pharmacist about all medicines and supplements.
Prescription-only, specialist-directed. Dose and duration depend on the locally approved indication, liver function, interacting medicines, and clinical response. Do not self-medicate or use generic dose schedules for Cushing’s syndrome or fungal disease. Follow the specific approved product information; monitor liver function as directed by the prescriber. Do not recommend cola or another acidic drink as a universal workaround for reduced absorption.
Major warnings: potentially fatal hepatotoxicity, QT prolongation and dangerous arrhythmias, adrenal insufficiency, and extensive CYP3A4-mediated drug interactions. Ketoconazole may be contraindicated in liver disease and with numerous medicines. Seek urgent care for jaundice, dark urine, severe fatigue, fainting, palpitations, or severe vomiting. Pregnancy, breastfeeding, and pediatric use require specialist assessment. The precise contraindication list must follow the destination country’s current approved label.
Store according to the approved product label, in the original packaging, protected from excess heat and moisture. The stated below-25°C limit must be confirmed for the actual marketed batch. Keep out of reach of children.