Aminosalicylate
Where is Mesalamine made?
30 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 25 factories in India, the United States, China, Canada, Italy, Germany and 1 other.
India 14United States 3China 3Canada 2Italy 1Germany 1Denmark 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. Lialda, Pentasa1.2 g, 250 mg, 500 mg · NDC 54092-476, 54092-100, 54092-189 +1 | Cosmo SpAMakes it and tests it | Lainate, Italy | Problems found, fixed voluntarilyNov 2022 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| PharmaZell GmbHMakes the active ingredient | Raubling, Germany | Problems found, fixed voluntarilyJun 2022 | |
| Pharmazell (India) Private LimitedMakes the active ingredient | Anakapalli, India | Problems found, fixed voluntarilyFeb 2025 | |
| Syntese A/SMakes the active ingredient and tests it | Hvidovre, Denmark | Problems found, fixed voluntarilyMay 2023 | |
| Cadila Healthcare Limited0.375 g, 1.2 g, 800 mg, 1000 mg · NDC 70771-1625, 70771-1071, 70771-1513 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 | |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 | |
| Caraco Pharmaceutical Laboratories, Ltd.1.2 g, 500 mg · NDC 63304-175, 63304-089 | Sun Pharmaceutical Industries LimitedMakes it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Sun Pharmaceutical Industries LimitedMakes the active ingredient | Ahilyanagar (formerly known as Ahmednagar), India | No problems foundSep 2026 | |
| Sun Pharmaceutical Industries LimitedMakes it | Mohali, India | Serious problems, FDA actionAug 2022 | |
| Zydus Pharmaceuticals (USA) Inc.0.375 g, 1.2 g, 800 mg, 1000 mg · NDC 68382-452, 68382-711, 70710-1302 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 | |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 | |
| Northstar Rx LLC.1.2 g, 1000 mg · NDC 72603-304, 16714-245 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 | |
| Salix Pharmaceuticals, Inc. Apriso375 mg · NDC 65649-103 | Bausch Health Companies Inc.Makes it | Steinbach, Canada | No problems foundMay 2023 |
| Catalent Pharma Solutions, LLCMakes it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 | |
| Teva Pharmaceuticals USA, Inc.375 mg, 400 mg · NDC 0093-9224, 0093-5907 | Bausch Health Companies Inc.Makes it | Steinbach, Canada | No problems foundMay 2023 |
| Catalent Pharma Solutions, LLCMakes it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 | |
| Alembic Pharmaceuticals Inc.0.375 g · NDC 62332-724 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited0.375 g · NDC 46708-724 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals800 mg · NDC 65162-360 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Ascend Laboratories, LLC0.375 g · NDC 67877-717 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited0.375 g · NDC 59651-397 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Camber Pharmaceuticals Inc.1.2 g, 375 mg, 1000 mg · NDC 31722-043, 31722-005, 31722-489 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Encube Ethicals, Inc.4 g per 60 mL · NDC 21922-045 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Ingenus Pharmaceuticals, LLC0.375 g · NDC 50742-371 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| KLM Laboratories Private Limited4 g per 60 mL · NDC 84725-002 | KLM Laboratories Private LimitedMakes it and tests it | Vadodara, India | Not inspected on record |
| Lannett Company, Inc.1.2 g · NDC 0527-3012 | Haimen Pharma Inc.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyAug 2023 |
| Nordic Pharma, Inc.1000 mg · NDC 69918-560 | Confab Laboratories Inc.Makes it, tests it, packages it and labels it | Saint Hubert, Canada | No problems foundFeb 2023 |
| Nuvaila Limited1.2 g · NDC 84612-175 | Sun Pharmaceutical Industries LimitedMakes it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Rising Pharma Holdings, Inc.1000 mg · NDC 16571-246 | Bliss GVS Pharma LimitedMakes it, tests it, packages it and labels it | Palghar, India | Problems found, fixed voluntarilyMar 2023 |
| Upsher-Smith Laboratories, Inc.0.375 g · NDC 0832-6056 | Yichang Humanwell Oral Solid Dosage PlantMakes it | Yichang, China | No problems foundJul 2023 |
| ANI Pharmaceuticals, Inc.4 g per 60 mL · NDC 62559-420, 70954-301 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Actavis Pharma, Inc.1.2 g, 1000 mg · NDC 0591-2245, 0472-1915 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Allergan, Inc. Canasa1000 mg · NDC 58914-501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.1.2 g · NDC 62135-714 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.375 g · NDC 0378-1375 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd4 g per 60 mL · NDC 45802-929, 45802-923, 45802-098 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.250 mg, 500 mg · NDC 0781-2791, 0781-2793 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.800 mg · NDC 0480-7750 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Rowasa4 g per 60 mL · NDC 0037-0066 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Mesalamine 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:
50090-4168,50090-3497 - American Health Packaging:
60687-650,60687-397,60687-556,60687-408 - AvKARE, Inc.:
42291-489 - AvPAK:
50268-577 - Avera McKennan Hospital:
69189-0189 - Bryant Ranch Prepack:
72162-2213,72162-2231,63629-2397,72162-2302+2 - Carilion Materials Management:
68151-4769,68151-5652 - Golden State Medical Supply, Inc.:
51407-976,51407-900 - Major Pharmaceuticals:
0904-6832 - Physicians Total Care, Inc.:
54868-6147,54868-6150 - State of Florida DOH Central Pharmacy:
53808-0205,53808-0823
Recalls
- Feb 5, 2024 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications: Out of specification for dissolution. - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - Oct 28, 2020 · Class II · Teva Pharmaceuticals USA
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. - Feb 20, 2020 · Class II · Teva Pharmaceuticals USA
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. - Dec 2, 2016 · Class III · Shire PLC
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.