Antimalarial, Antiprotozoal
Where is Atovaquone made?
14 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 7 factories in the United States and India.
United States 5India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA750 mg per 5 mL · NDC 68462-421 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Solan, India | Serious problems, FDA actionJun 2022 |
| PPL Healthcare LLCMakes it | Sellersville, PA, United States | Problems found, fixed voluntarilyMay 2026 | |
| Amneal Pharmaceuticals750 mg per 5 mL · NDC 65162-693 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 |
| Bionpharma Inc.750 mg per 5 mL · NDC 69452-252 | Corerx, Inc.Makes it | Clearwater, FL, United States | Problems found, fixed voluntarilyFeb 2026 |
| Camber Pharmaceuticals Inc.750 mg per 5 mL · NDC 31722-629 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| KVK-TECH, Inc.750 mg per 5 mL · NDC 10702-223 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Lupin Pharmaceuticals, Inc.750 mg per 5 mL · NDC 70748-299 | Hetero Labs LimitedMakes it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Northstar Rx LLC.750 mg per 5 mL · NDC 72603-248 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Pharmaceutical Associates, Inc.750 mg per 5 mL · NDC 0121-1016, 0121-0956 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, tests it, packages it and labels it | Greenville, SC, United States | No problems foundAug 2025 |
| Abon Pharmaceuticals, LLC750 mg per 5 mL · NDC 42239-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.750 mg per 5 mL · NDC 68999-528 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.750 mg per 5 mL · NDC 62135-528 | The label doesn't name the factory. Plants this company names for other drugs | ||
| GlaxoSmithKline LLC Mepron750 mg per 5 mL · NDC 0173-0665, 0173-0547 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kesin Pharma Corporation750 mg per 5 mL · NDC 81033-105 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Major Pharmaceuticals750 mg per 5 mL · NDC 0904-7459 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Atovaquone 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.
- American Health Packaging:
60687-534 - Atlantic Biologicals Corps.:
17856-0631,17856-8631 - AvKARE, Inc.:
73190-098 - AvPAK:
50268-119 - Golden State Medical Supply, Inc.:
51407-642 - Kesin Pharma Corporation:
81033-104 - Lohxa:
70166-488
Recalls
- Sep 17, 2024 · Class I · Bionpharma Inc.
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. - Mar 13, 2023 · Class I · Camber Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. - Jul 2, 2021 · Class I · KVK-Tech, Inc.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.