Bile Acid Sequestrant
Where is Colesevelam made?
10 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 9 factories in India and Austria.
India 8Austria 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bionpharma Inc.625 mg · NDC 69452-158, 69452-493, 69452-582 | OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 |
| Patheon Austria GmbH & CoKGMakes the active ingredient | Linz, Austria | Problems found, fixed voluntarilySep 2024 | |
| Glenmark Pharmaceuticals Inc., USA3.75 g, 625 mg · NDC 68462-620, 68462-433 | 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 | |
| Amneal Pharmaceuticals3.75 g, 625 mg · NDC 0115-1864, 0115-1320 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Ascend Laboratories, LLC3.75 g, 625 mg · NDC 67877-523, 67877-506 | Alkem Laboratories LimitedMakes it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Cadila Healthcare Limited625 mg · NDC 70771-1368 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Dr. Reddy's Laboratories Inc.625 mg · NDC 43598-230 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Macleods Pharmaceuticals Limited625 mg · NDC 33342-197 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Zydus Pharmaceuticals (USA) Inc.625 mg · NDC 68382-619 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Cosette Pharmaceuticals, Inc. Welchol, Colesevelam Hydrochloride3.75 g, 625 mg · NDC 0713-0880, 0713-0935, 0713-0879 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC625 mg · NDC 27808-190 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Colesevelam 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:
50090-6995,50090-6994,50090-7460,50090-7459+4 - American Health Packaging:
60687-385 - Bryant Ranch Prepack:
63629-8860,72162-1847,72162-1846,71335-2905+1 - Carilion Materials Management:
68151-4362 - Golden State Medical Supply, Inc.:
51407-336 - PD-Rx Pharmaceuticals, Inc.:
72789-476 - Physicians Total Care, Inc.:
54868-6136,54868-4474 - Rebel Distributors Corp..:
21695-779,21695-781
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.