HMG-CoA Reductase Inhibitor
Where is Pravastatin made?
15 companies sell it under their own name and 27 repackagers rebottle it. Their labels name 12 factories in India, the United States, the Czech Republic and Israel.
India 7United States 3Czech Republic 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited10 mg, 20 mg, 40 mg, 80 mg · NDC 84386-031, 65862-632, 84386-032 +6 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Teva Czech Industries s.r.o.Makes it, tests it, packages it and labels it | Opava, Czech Republic | Problems found, fixed voluntarilyAug 2024 | |
| Teva Pharmaceutical Industries Ltd.Makes it, tests it, packages it and labels it | Kfar Saba, Israel | Problems found, fixed voluntarilyMay 2023 | |
| Glenmark Pharmaceuticals Inc., USA10 mg, 20 mg, 40 mg, 80 mg · NDC 68462-195, 68462-196, 68462-197 +1 | Glenmark Pharmaceuticals Inc., USAMakes it and tests it | Monroe, NC, United States | Problems found, fixed voluntarilyJun 2025 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 | |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 | |
| Northstar Rx LLC.10 mg, 20 mg, 40 mg, 80 mg · NDC 16714-558, 16714-559, 16714-560 +1 | Glenmark Pharmaceuticals Inc., USAMakes it and tests it | Monroe, NC, United States | Problems found, fixed voluntarilyJun 2025 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 | |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 | |
| Accord Healthcare Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 16729-008, 16729-009, 16729-010 +1 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Biocon Pharma Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 70377-045, 70377-046, 70377-047 +1 | Appco Pharma LLCMakes it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Biocon Generics IncMakes it | Cranbury, NJ, United States | Problems found, fixed voluntarilyOct 2025 | |
| Cipla USA., Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 69097-788, 69097-789, 69097-791 +1 | Glenmark Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Glenmark Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Dhar, India | Serious problems, FDA actionFeb 2025 | |
| Dr.Reddy's Laboratories Ltd.10 mg, 20 mg, 40 mg, 80 mg · NDC 55111-229, 55111-230, 55111-231 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lupin Pharmaceuticals, Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 68180-485, 68180-486, 68180-487 +1 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Amici Pharma Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 69292-101, 69292-102, 69292-103 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.10 mg, 20 mg, 40 mg, 80 mg · NDC 60505-0168, 60505-0169, 60505-0170 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.10 mg, 20 mg, 40 mg, 80 mg · NDC 62135-847, 62135-848, 62135-849 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| International Laboratories, LLC20 mg, 40 mg · NDC 54458-869, 54458-926, 54458-867 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Quallent Pharmaceuticals Health LLC20 mg, 40 mg, 80 mg · NDC 82009-006, 82009-007, 82009-008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg, 20 mg, 40 mg · NDC 0093-0771, 0093-7201, 0093-7202 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.80 mg · NDC 0480-7270 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pravastatin 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:
50090-1594,50090-3853,50090-0975,50090-6898+24 - Aidarex Pharmaceuticals LLC:
53217-203,33261-867,33261-868,33261-953+1 - American Health Packaging:
60687-886,60687-897,60687-908 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-474,43353-927,71610-879,71610-884+2 - AvPAK:
50268-665,50268-666,50268-667,50268-668 - Blenheim Pharmacal, Inc.:
10544-440,10544-505,10544-507 - Bryant Ranch Prepack:
63629-8904,63629-9162,71335-1243,71335-2298+27 - Cardinal Health 107, LLC:
55154-3350,55154-7275,55154-7998 - Coupler LLC:
67046-1518,67046-1621,67046-1519 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-358,70934-236,70934-161,70934-832 - Direct Rx:
61919-707,72189-059,61919-709,61919-731+7 - Golden State Medical Supply, Inc.:
51407-887,51407-888,51407-889,51407-890 - International Laboratories, LLC:
54458-927 - Lake Erie Medical DBA Quality Care Products LLC:
35356-921,35356-919,35356-125 - Major Pharmaceuticals:
0904-5891,0904-5892,0904-5893 - MedVantx, Inc.:
66116-346 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8539,0615-8618,0615-8540,0615-8619+4 - Northwind Pharmaceuticals:
82868-104,82868-091,82868-096,82868-081+3 - NuCare Pharmaceuticals.Inc.:
68071-5001,68071-5007,68071-3361,68071-3788+2 - PD-Rx Pharmaceuticals, Inc.:
43063-807,72789-143,43063-808,72789-161 - Physicians Total Care, Inc.:
54868-5576,54868-5577,54868-5578,54868-5579 - Preferred Pharmaceuticals, Inc..:
68788-4059,68788-8425,68788-8871,68788-4049+4 - Proficient Rx LP:
71205-149,71205-121,71205-516,71205-294 - Rebel Distributors Corp..:
21695-178,21695-179,42254-202,21695-180+1 - Remedyrepack Inc.:
70518-0549,70518-1938,70518-4408,70518-0876+1 - Safecor Health, LLC:
48433-148,48433-149 - State of Florida DOH Central Pharmacy:
53808-0765,53808-0764,53808-0685,53808-0766+6
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 4 recall notices
CGMP Deviations - Jun 28, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: results below specifications - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 4 recall notices
CGMP Deviations: recalling drug products following an FDA inspection. - Mar 25, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. - Jan 12, 2018 · Class II · International Laboratories, Inc. · 2 recall notices
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. - Nov 17, 2017 · Class II · Lupin Limited
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle. - Aug 7, 2017 · Class I · International Laboratories, Inc.
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg. - Jul 11, 2017 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. - Apr 5, 2013 · Class III · Glenmark Generics Inc., USA
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.