Antimetabolite Immunosuppressant
Where is Mycophenolic Acid made?
38 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 26 factories in India, the United States, China, Italy and Germany.
India 15United States 6China 3Italy 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Pharma Inc.180 mg, 360 mg · NDC 70377-126, 70377-039, 70377-127 +1 | Acme Generics Private LimitedMakes it | Solan, India | Problems found, fixed voluntarilyFeb 2026 |
| Biocon LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilySep 2024 | |
| Biocon Pharma LimitedMakes it, tests it and packages it | Bengaluru, India | No problems foundJun 2023 | |
| Accord Healthcare Inc.180 mg, 250 mg, 360 mg, 500 mg · NDC 16729-261, 16729-094, 16729-189 +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 | |
| Amneal Pharmaceuticals200 mg per 1 mL · NDC 60219-1595, 69238-1595 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Camber Pharmaceuticals Inc.250 mg, 500 mg · NDC 31722-878, 31722-879 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 | |
| Advagen Pharma Ltd.180 mg, 250 mg, 360 mg, 500 mg · NDC 72888-199, 72888-192, 72888-200 +1 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Archis Pharma LLC180 mg, 360 mg · NDC 72819-155, 72819-156 | RK Pharma Inc.Makes it | Pearl River, NY, United States | Problems found, fixed voluntarilyMay 2024 |
| Armas Pharmaceuticals Inc.500 mg per 20 mL · NDC 72485-415 | Onesource Specialty Pharma LimitedMakes it and packages it | Bengaluru Rural, India | Problems found, fixed voluntarilyMar 2025 |
| Ascend Laboratories, LLC180 mg, 200 mg per 1 mL, 250 mg, 360 mg, 500 mg · NDC 67877-426, 67877-928, 67877-230 +4 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited180 mg, 200 mg per 1 mL, 250 mg, 360 mg, 500 mg · NDC 59651-621, 59651-646, 59651-624 +2 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| BPI Labs, LLC500 mg per 20 mL · NDC 54288-141 | Bioindustria Laboratorio Italiano Medicinali S.p.AMakes it and tests it | Novi Ligure, Italy | Problems found, fixed voluntarilyJul 2025 |
| Concord Biotech Limited180 mg, 250 mg, 360 mg, 500 mg · NDC 68254-5001, 68254-5000, 68254-5002 +1 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Genentech, Inc. CellCept200 mg per 1 mL, 250 mg, 500 mg, 500 mg per 20 mL · NDC 0004-0261, 0004-0259, 0004-0260 +1 | Roche Diagnostics GmbHMakes it and tests it | Mannheim, Germany | Problems found, fixed voluntarilyOct 2021 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.200 mg per 1 mL, 250 mg, 500 mg · NDC 23155-848, 23155-830, 23155-836 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc.250 mg, 500 mg · NDC 0054-0163, 0054-0166 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Meitheal Pharmaceuticals Inc.500 mg per 20 mL · NDC 71288-803 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Mylan Institutional LLC500 mg per 20 mL · NDC 67457-386 | Mylan Laboratories LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bengaluru, India | No problems foundFeb 2023 |
| Northstar Rx LLC.200 mg per 1 mL · NDC 72603-751 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Novugen Pharma (USA) LLC.180 mg, 360 mg · NDC 82293-012, 82293-013 | Aizant Drug Research Solutions PVT LtdMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2026 |
| Onesource Specialty Pharma Limited500 mg per 20 mL · NDC 83270-000 | Onesource Specialty Pharma LimitedMakes it and tests it | Bengaluru Rural, India | Problems found, fixed voluntarilyMar 2025 |
| Praxis, LLC Myhibbin200 mg per 1 mL · NDC 59368-403 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| Quagen Pharmaceuticals LLC200 mg per 1 mL · NDC 70752-294 | Lannett Company, LLCMakes it, tests it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Rising Pharma Holdings, Inc.200 mg per 1 mL · NDC 16571-282 | Corerx, Inc.Makes it, tests it, packages it and labels it | Clearwater, FL, United States | Problems found, fixed voluntarilyFeb 2026 |
| Slate Run Pharmaceuticals, LLC.180 mg, 360 mg · NDC 70436-172, 70436-173 | Yichang Humanwell Oral Solid Dosage PlantMakes it | Yichang, China | No problems foundJul 2023 |
| Stellon Biotech Inc.180 mg, 360 mg · NDC 85972-161, 85972-162 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Strides Pharma Science Limited200 mg per 1 mL, 250 mg, 500 mg · NDC 64380-899, 64380-726, 64380-725 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Wuxi Fortune Pharmaceutical Co.,Ltd.250 mg · NDC 65050-2073 | Wuxi Fortune Pharmaceutical Co., Ltd.Makes it | Wuxi, China | Problems found, fixed voluntarilyNov 2024 |
| airis PHARMA Private Limited180 mg, 360 mg · NDC 71151-030, 71151-031 | Acme Generics Private LimitedMakes it | Solan, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals LLC500 mg per 20 mL · NDC 70121-1584 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.180 mg, 360 mg · NDC 60505-2965, 60505-2966 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Myhibbin200 mg per 1 mL · NDC 24338-018 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.500 mg per 20 mL · NDC 42023-172 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.200 mg per 1 mL · NDC 0527-5160 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.250 mg, 500 mg · NDC 0378-2250, 0378-4472 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Myfortic180 mg, 360 mg · NDC 0078-0385, 0078-0386 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.250 mg, 500 mg · NDC 0781-2067, 0781-5175 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.250 mg · NDC 0093-7334 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Vensun Pharmaceuticals, Inc.250 mg, 500 mg · NDC 42543-988, 42543-989 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VistaPharm, LLC200 mg per 1 mL · NDC 66689-307 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Mycophenolic Acid 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:
50090-6492,50090-4275 - American Health Packaging:
68084-907,60687-885,68084-918,60687-438 - AvKARE, Inc.:
73190-009,73190-010 - AvPAK:
50268-557,50268-558 - Avera McKennan Hospital:
69189-0164 - Bryant Ranch Prepack:
63629-9582 - Cardinal Health 107, LLC:
55154-0161,55154-3571 - Golden State Medical Supply, Inc.:
60429-016,60429-017 - Major Pharmaceuticals:
0904-6785,0904-7466,0904-7372,0904-6786+1 - NuCare Pharmaceuticals.Inc.:
68071-3767 - Proficient Rx LP:
82804-033 - Rebel Distributors Corp..:
21695-171 - Remedyrepack Inc.:
70518-3799,70518-4036,70518-4391,70518-2767+1
Recalls
- Aug 26, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications - Jul 2, 2026 · Class II · Mylan Pharmaceuticals Inc
Presence of precipitate - Sep 3, 2024 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications - Oct 26, 2023 · Class III · VistaPharm LLC
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. - Apr 30, 2019 · Class I · Par Pharmaceutical, Inc.
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product - Sep 27, 2012 · Class III · Genentech, Inc.
Short Fill: some bottles contained less than 120-count per labeled claim.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.