Bile Acid
Where is Ursodiol made?
23 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 11 factories in India and the United States.
India 8United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cadila Healthcare Limited250 mg, 300 mg, 500 mg · NDC 70771-1407, 70771-1524, 70771-1408 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Zydus Pharmaceuticals (USA) Inc.250 mg, 300 mg, 500 mg · NDC 70710-1127, 70710-1483, 70710-1128 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Actavis Pharma, Inc.300 mg · NDC 0591-3159 | Watson Pharma Private LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJan 2020 |
| Aurobindo Pharma Limited300 mg · NDC 59651-421 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| BluePoint Laboratories.250 mg, 500 mg · NDC 68001-377, 68001-378 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Epic Pharma, LLC300 mg · NDC 42806-503 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| FH2 Pharma LLC200 mg, 400 mg · NDC 72887-143, 72887-144 | LGM Pharma Solutions, LLCMakes it | Irvine, CA, United States | No problems foundJan 2025 |
| Glenmark Pharmaceuticals Inc., USA250 mg, 500 mg · NDC 68462-473, 68462-474 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Intra-Sana Laboratories200 mg, 400 mg · NDC 80056-143, 80056-144 | LGM Pharma Solutions, LLCMakes it | Irvine, CA, United States | No problems foundJan 2025 |
| LGM Pharma Solutions, LLC200 mg, 400 mg · NDC 79739-7143, 79739-7144 | LGM Pharma Solutions, LLCMakes it, tests it, packages it and labels it | Irvine, CA, United States | No problems foundJan 2025 |
| Lannett Company, Inc.300 mg · NDC 0527-1326 | Lannett Company, LLCMakes it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Laurus Labs Limited300 mg · NDC 42385-946 | Laurus Labs LimitedMakes it, makes the active ingredient and tests it | Anakapalli, India | Problems found, fixed voluntarilyFeb 2023 |
| Nexgen Pharma, Inc.200 mg, 400 mg · NDC 0722-7143, 0722-7144 | Nexgen Pharma, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Northstar Rx LLC.300 mg · NDC 72603-613 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Pangea Pharmaceuticals LLC150 mg · NDC 81279-130 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals300 mg · NDC 24658-999, 24658-780 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Strides Pharma Science Limited250 mg, 300 mg, 500 mg · NDC 64380-918, 64380-844, 64380-919 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| VGYAAN Pharmaceuticals LLC300 mg · NDC 72664-217 | Aizant Drug Research Solutions PVT LtdMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2026 |
| Allergan, Inc. Urso 250, Urso Forte250 mg, 500 mg · NDC 58914-785, 58914-790 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals300 mg · NDC 69238-1540 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.300 mg · NDC 62135-430 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.250 mg, 500 mg · NDC 49884-412, 49884-413 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.300 mg · NDC 10135-543 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ursodiol 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:
60687-527,60687-100 - AvKARE, Inc.:
42291-923,42291-931 - AvPAK:
50268-797,50268-864 - Avera McKennan Hospital:
69189-0413 - Bryant Ranch Prepack:
72162-1500,63629-2286,72162-2168,72162-2619+2 - Cardinal Health 107, LLC:
55154-2633 - Carilion Materials Management:
68151-2987 - Golden State Medical Supply, Inc.:
51407-754 - Major Pharmaceuticals:
0904-6890,0904-6221 - PD-Rx Pharmaceuticals, Inc.:
72789-205 - Physicians Total Care, Inc.:
54868-5033 - Stat Rx USA:
16590-349