HMG-CoA Reductase Inhibitor
Where is Pitavastatin made?
13 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 10 factories in India, Taiwan, Japan and the United States.
India 6Taiwan 2Japan 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc. Nikita1 mg, 2 mg, 4 mg · NDC 68180-742, 68180-735, 68180-743 +3 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 | |
| Amneal Pharmaceuticals1 mg, 2 mg, 4 mg · NDC 65162-029, 65162-030, 65162-031 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Aurobindo Pharma Limited1 mg, 2 mg, 4 mg · NDC 65862-812, 65862-813, 65862-814 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited Zypitamag1 mg, 2 mg, 4 mg · NDC 70771-1784, 70771-1117, 70771-1785 +2 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.1.045 mg, 2.09 mg, 4.18 mg · NDC 31722-875, 31722-876, 31722-877 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Kowa Pharmaceuticals America, Inc. Livalo1.045 mg, 2.09 mg, 4.18 mg · NDC 66869-104, 66869-204, 66869-404 | Kowa Company, Ltd.Makes it | Nagoya, Japan | No problems foundSep 2023 |
| Medicure International Inc Zypitamag2 mg, 4 mg · NDC 25208-201, 25208-202 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Northstar Rx LLC.2.09 mg, 4.18 mg · NDC 72603-479, 72603-480 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Teva Pharmaceuticals, Inc.1.045 mg, 2.09 mg, 4.18 mg · NDC 0480-3631, 0480-3632, 0480-3633 | Orient Pharma Co., Ltd. Yunlin PlantMakes it | Yunlin County, Taiwan | No problems foundMay 2025 |
| Upsher-Smith Laboratories, Inc.1 mg, 2 mg, 4 mg · NDC 0832-6048, 0832-6049, 0832-6050 | Standard Chem. & Pharm. Co., Ltd. Plant IIMakes it and tests it | Tainan City, Taiwan | No problems foundNov 2022 |
| XLCare Pharmaceuticals, Inc.1 mg, 2 mg, 4 mg · NDC 72865-291, 72865-292, 72865-293 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.1 mg, 2 mg, 4 mg · NDC 68382-481, 68382-482, 68382-483 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Mylan Pharmaceuticals Inc.1 mg, 2 mg, 4 mg · NDC 0378-5055, 0378-5056, 0378-5057 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pitavastatin 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.
- AvKARE, Inc.:
42291-905,42291-906,42291-907 - Golden State Medical Supply, Inc.:
51407-956,51407-957,51407-958
Recalls
- Feb 3, 2026 · Class III · Annora Pharma Private Limited
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg - Jun 26, 2025 · Class III · AvKARE · 2 recall notices
Failed Impurity/Degradation Specifications - Jun 11, 2025 · Class III · Orient Pharma Co., Ltd. Yunlin Plant · 2 recall notices
Failed Impurities/Degradation Specifications. - Feb 24, 2025 · Class III · Kowa Pharmaceuticals America
Presence of foreign tablets/capsules - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.