Azole Antifungal
Where is Ketoconazole made?
19 companies sell it under their own name and 20 repackagers rebottle it. Their labels name 8 factories in India, Israel, the United States, Canada and Spain.
India 3Israel 2United States 1Canada 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.20 mg per 1 g, 200 mg · NDC 51672-1298, 51672-4026 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| ANI Pharmaceuticals, Inc.20 mg per 1 mL · NDC 70954-662 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Cadila Healthcare Limited20 mg per 1 mL · NDC 70771-1874 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Encube Ethicals, Inc.20 mg per 1 g · NDC 21922-025 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Esjay Pharma LLC200 mg · NDC 70685-001 | Esjay Pharma Private LimitedMakes it, tests it, packages it and labels it | Kancheepuram, India | Not inspected on record |
| Golden State Medical Supply, Inc.20 mg per 1 g · NDC 51407-279 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Medimetriks Pharmaceuticals, Inc.20 mg per 1 g · NDC 43538-530 | Padagis Israel Pharmaceuticals LtdMakes it | Yeruham, Israel | No problems foundOct 2022 |
| Northstar Rx LLC.20 mg per 1 g, 20 mg per 1 mL · NDC 16714-955, 72603-878 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Viona Pharmaceuticals Inc.20 mg per 1 mL · NDC 72578-156 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Xiromed, LLC.20 mg per 1 g · NDC 70700-160 | Laboratorios Liconsa SAUMakes it | Azuqueca De Henares, Spain | Problems found, fixed voluntarilyJan 2025 |
| Amerisyn, LLC200 mg · NDC 87564-051 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amici Pharma Inc.200 mg · NDC 69292-224 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Burel Pharmaceuticals, LLC200 mg · NDC 35573-433 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cosette Pharmaceuticals, Inc.20 mg per 1 mL · NDC 0713-0592 | The label doesn't name the factory. Plants this company names for other drugs | ||
| E. FOUGERA & CO., A division of Nycomed US Inc.20 mg per 1 g · NDC 0168-0099 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ipg Pharmaceuticals, Inc.20 mg per 1 g · NDC 71085-008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd2 g per 100 g, 20 mg per 1 mL · NDC 45802-532, 45802-465 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Strides Pharma Science Limited200 mg · NDC 64380-827 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.20 mg per 1 g · NDC 0093-3219 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ketoconazole in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-6069,50090-5265,50090-6046,50090-1524+6 - Aidarex Pharmaceuticals LLC:
53217-015,33261-739 - Asclemed USA, Inc.:
87063-066 - Bryant Ranch Prepack:
63629-8676,63629-8677,72162-1417,71335-2941+8 - Carilion Materials Management:
68151-2713 - Direct Rx:
61919-841,72189-422,72189-180,72189-428 - Dispensing Solutions Inc.:
68258-3998 - Golden State Medical Supply, Inc.:
60429-020 - NuCare Pharmaceuticals.Inc.:
68071-2309,68071-2847,68071-1709,68071-3512+5 - PD-Rx Pharmaceuticals, Inc.:
72789-052 - Physicians Total Care, Inc.:
54868-4448,54868-5645,54868-5071 - Preferred Pharmaceuticals, Inc..:
68788-8233,68788-9903,68788-8868,68788-8257 - Proficient Rx LP:
63187-774,82804-091,71205-105 - RPK Pharmaceuticals, Inc.:
53002-8151,53002-8150 - Rebel Distributors Corp..:
21695-554,21695-555,21695-556,21695-562 - RedPharm Drug. Inc.:
67296-0448,67296-0540,67296-2089,67296-1807 - Remedyrepack Inc.:
70518-4236 - Sportpharm LLC:
85766-135 - Stat Rx USA:
16590-998 - State of Florida DOH Central Pharmacy:
53808-0842
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Nov 18, 2013 · Class III · Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. - Jul 18, 2012 · Class III · Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.