HMG-CoA Reductase Inhibitor
Where is Rosuvastatin made?
28 companies sell it under their own name and 25 repackagers rebottle it. Their labels name 31 factories in India, the United States, China and Bangladesh.
India 19United States 6China 5Bangladesh 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Pharma Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 70377-007, 70377-008, 70377-009 +1 | Biocon LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilySep 2024 |
| Biocon Pharma LimitedMakes it | Bengaluru, India | No problems foundJun 2023 | |
| Recipharm Pharmaservices Private LimitedMakes it | Bengaluru, India | No problems foundMar 2024 | |
| Glenmark Pharmaceuticals Inc., USA5 mg, 10 mg, 20 mg, 40 mg · NDC 68462-262, 68462-263, 68462-264 +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 | |
| Novadoz Pharmaceuticals LLC5 mg, 10 mg, 20 mg, 40 mg · NDC 72205-003, 72205-004, 72205-005 +2 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Laboratories Private LimitedMakes it and tests it | Rangareddy (District), India | Problems found, fixed voluntarilyJun 2024 | |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Torrent Pharma, Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 13668-180, 13668-721, 13668-181 +5 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it | Bharuch, India | No problems foundJan 2026 | |
| Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 | |
| Aurobindo Pharma Limited5 mg, 10 mg, 20 mg, 40 mg · NDC 65862-294, 65862-295, 65862-296 +1 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurolife Pharma LLCMakes it and tests it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Camber Pharmaceuticals Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 31722-883, 31722-884, 31722-885 +1 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Hetero Labs LimitedMakes it | Hobli Vemagal Kolar, India | No problems foundJan 2025 | |
| Northstar Rx LLC.5 mg, 10 mg, 20 mg, 40 mg · NDC 16714-989, 72603-365, 16714-990 +5 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 | |
| Quallent Pharmaceuticals Health LLC5 mg, 10 mg, 20 mg, 40 mg · NDC 82009-018, 82009-189, 82009-019 +5 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 | |
| Rising Pharma Holdings, Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 57237-169, 57237-170, 57237-171 +1 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurolife Pharma LLCMakes it and tests it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Accord Healthcare Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 16729-285, 16729-286, 16729-287 +1 | Intas Pharmaceuticals LimitedMakes it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| AiPing Pharmaceutical, Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 11788-131, 11788-132, 11788-133 +1 | Zhejiang Jingxin Pharmaceutical Co., Ltd.Makes it | Shaoxing, China | Problems found, fixed voluntarilyOct 2025 |
| Ascend Laboratories, LLC5 mg, 10 mg, 20 mg, 40 mg · NDC 67877-440, 67877-441, 67877-442 +1 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Cadila Pharmaceuticals Limited5 mg, 10 mg, 20 mg, 40 mg · NDC 71209-044, 71209-045, 71209-046 +1 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Chartwell RX, LLC.5 mg, 10 mg, 20 mg, 40 mg · NDC 62135-691, 62135-692, 62135-693 +1 | Chartwell Pharmaceuticals Congers, LLC.Makes it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Cranbury Pharmaceuticals, LLC5 mg, 10 mg, 20 mg, 40 mg · NDC 27808-156, 27808-157, 27808-158 +1 | Changzhou Pharmaceutical FactoryMakes it, tests it, packages it and labels it | Changzhou, China | Problems found, fixed voluntarilyJan 2024 |
| H.J. Harkins Co., Inc.10 mg, 40 mg · NDC 76519-1162, 76519-1153 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| HEC Pharm USA Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 72303-0828, 72303-0829, 72303-0830 +1 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Lifestar Pharma LLC.5 mg, 10 mg, 20 mg, 40 mg · NDC 70756-054, 70756-055, 70756-056 +1 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 68180-731, 68180-732, 68180-733 +1 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Macleods Pharmaceuticals Limited5 mg, 10 mg, 20 mg, 40 mg · NDC 33342-262, 33342-263, 33342-264 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| ScieGen Pharmaceuticals, Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 50228-117, 50228-118, 50228-119 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Shandong New Time Pharmaceutical Co., Ltd.5 mg, 10 mg, 20 mg, 40 mg · NDC 42677-302, 42677-303, 42677-304 +1 | Shandong New Time Pharmaceutical Co., Ltd.Makes it | Linyi, China | Problems found, fixed voluntarilyJul 2024 |
| Umedica Laboratories USA Inc.5 mg, 10 mg, 20 mg, 40 mg · NDC 60290-044, 60290-045, 60290-046 +1 | Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Westminster Pharmaceuticals, LLC5 mg, 10 mg, 20 mg, 40 mg · NDC 69367-360, 69367-361, 69367-362 +1 | Renata PLC (general Plant-2)Makes it, tests it, packages it and labels it | Gazipur, Bangladesh | Problems found, fixed voluntarilyJan 2020 |
| Zhejiang Yongtai Pharmaceutical Co., Ltd.5 mg, 10 mg, 20 mg, 40 mg · NDC 69434-006, 69434-007, 69434-008 +1 | Zhejiang Yongtai Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Taizhou, China | Problems found, fixed voluntarilyMar 2025 |
| AstraZeneca Pharmaceuticals LP Crestor5 mg, 10 mg, 20 mg, 40 mg · NDC 0310-7570, 0310-7580, 0310-7590 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PuraCap Laboratories LLC dba Blu Pharmaceuticals5 mg, 10 mg, 20 mg, 40 mg · NDC 24658-262, 24658-263, 24658-264 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Redpharm Drug10 mg · NDC 67296-2360 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Rosuvastatin 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:
50090-4039,50090-5056,50090-4738,50090-5188+61 - Aidarex Pharmaceuticals LLC:
53217-295,53217-296,53217-348,53217-297 - American Health Packaging:
60687-245,60687-256,60687-234 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-290,71610-215,71610-233,71610-801+12 - Atlantic Biologicals Corps.:
17856-0186,17856-0183 - AvPAK:
50268-709,50268-710,50268-711 - Avera McKennan Hospital:
69189-0752 - Bryant Ranch Prepack:
71335-1446,71335-1733,71335-1890,71335-0606+21 - Cardinal Health 107, LLC:
55154-0158,55154-0159 - Carilion Materials Management:
68151-4634 - Coupler LLC:
67046-1627 - Direct Rx:
61919-786,61919-701,61919-712,72189-106+2 - Golden State Medical Supply, Inc.:
51407-849,51407-850,51407-851,51407-848 - H.J. Harkins Co., Inc.:
52959-629 - Medsource Pharmaceuticals:
45865-893,45865-894 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8533,0615-8534,0615-8535,0615-8532 - Northwind Pharmaceuticals:
51655-256,51655-062,51655-996,51655-235+5 - NuCare Pharmaceuticals.Inc.:
68071-2326,68071-2634,68071-2637,68071-2760+14 - Physicians Total Care, Inc.:
54868-4963,54868-5085,54868-1890,54868-5341 - Preferred Pharmaceuticals, Inc..:
68788-4057,68788-8384,68788-8775,68788-4047+7 - Proficient Rx LP:
63187-864,71205-052,71205-008,71205-820+15 - QPharma, Inc.:
42708-190,42708-191 - Rebel Distributors Corp..:
21695-287,21695-288,21695-659,21695-759 - RedPharm Drug. Inc.:
67296-2288,67296-2289,67296-1887,67296-1515 - Remedyrepack Inc.:
70518-4143,70518-3639,70518-4303,70518-1819+8
Recalls
- Dec 31, 2025 · Class II · AvKARE
Out of specification for dissolution. - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 4 recall notices
CGMP Deviations: recalling drug products following an FDA inspection.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.