Proton Pump Inhibitor
Where is Pantoprazole made?
40 companies sell it under their own name and 43 repackagers rebottle it. Their labels name 30 factories in India, the United States, Germany, Turkey and China.
India 22United States 4Germany 2Turkey 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Northstar Rx LLC.20 mg, 40 mg, 40 mg per 10 mL · NDC 72603-177, 72603-178, 72603-317 +2 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 | |
| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 | |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Mohali, India | Serious problems, FDA actionAug 2022 | |
| Camber Pharmaceuticals Inc.20 mg, 40 mg · NDC 31722-712, 31722-032, 31722-713 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 | |
| Ciron Drugs and Pharmaceuticals PVT LtdMakes it | Tarapur, India | Not inspected on record | |
| Caraco Pharmaceutical Laboratories, Ltd.40 mg, 40 mg per 10 mL · NDC 62756-071, 62756-129, 70095-024 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 | |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Mohali, India | Serious problems, FDA actionAug 2022 | |
| Aurobindo Pharma Limited20 mg, 40 mg · NDC 65862-559, 59651-671, 65862-560 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Cipla USA., Inc.40 mg · NDC 69097-531 | Cipla LimitedMakes it and tests it | Pune, India | Problems found, fixed voluntarilyMay 2024 |
| Cipla LimitedMakes the active ingredient and tests it | Bengaluru, India | Problems found, fixed voluntarilyNov 2024 | |
| Gland Pharma Limited40 mg per 10 mL · NDC 68083-493 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Ranbaxy Laboratories Inc.20 mg, 40 mg · NDC 63304-967, 63304-968 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Ranbaxy laboratories Limited ToansaMakes the active ingredient | Location not on file | Not inspected on record | |
| Torrent Pharma, Inc.20 mg, 40 mg · NDC 13668-096, 13668-429 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. ProtonixDelayed-Release, ProtonixI.V.20 mg, 40 mg, 40 mg per 10 mL · NDC 0008-0843, 0008-0841, 0008-0844 +2 | Takeda GmbHMakes it, tests it, packages it and labels it | Oranienburg, Germany | Problems found, fixed voluntarilyNov 2025 |
| Takeda GmbHMakes it, tests it, packages it and labels it | Singen (Hohentwiel), Germany | Problems found, fixed voluntarilyNov 2025 | |
| Ajanta Pharma USA Inc.40 mg · NDC 27241-256 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Alembic Pharmaceuticals Inc.40 mg per 10 mL · NDC 62332-071 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Alembic Pharmaceuticals Limited40 mg per 10 mL · NDC 46708-071 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals20 mg, 40 mg · NDC 65162-636, 65162-637 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| AuroMedics Pharma LLC40 mg · NDC 55150-202 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BE Pharmaceuticals Inc.40 mg per 10 mL · NDC 71839-122 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Baxter Healthcare Corporation Pantoprazole Sodium40 mg per 100 mL, 40 mg per 50 mL, 80 mg per 100 mL · NDC 0338-9644, 0338-9646, 0338-9648 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Round Lake, IL, United States | Serious problems, FDA actionApr 2026 |
| Burel Pharmaceuticals, LLC40 mg · NDC 35573-428 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Devatis, Inc.40 mg per 10 mL · NDC 73043-020 | Deva Holding A S-Kartepe Uretim TesisleriMakes it | Kocaeli, Turkey | No problems foundDec 2023 |
| Dr.Reddy's Laboratories Ltd.20 mg, 40 mg · NDC 55111-332, 55111-333 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLC40 mg per 10 mL · NDC 65219-385 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Granules Pharmaceuticals Inc.20 mg, 40 mg · NDC 70010-190, 70010-191 | Granules India LimitedMakes it, tests it, packages it and labels it | Medchal-Malkajgiri District, India | Problems found, fixed voluntarilyFeb 2020 |
| Lifestar Pharma LLC.20 mg, 40 mg · NDC 70756-018, 70756-019 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Meitheal Pharmaceuticals Inc.40 mg per 10 mL · NDC 71288-600 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| New Horizon Rx Group, LLC40 mg · NDC 58517-420 | Sun Pharmaceutical Industries LimitedMakes it | Halol, India | Serious problems, FDA actionJun 2025 |
| Novadoz Pharmaceuticals LLC40 mg per 10 mL · NDC 72205-180 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Rising Pharma Holdings, Inc.20 mg, 40 mg · NDC 64980-676, 64980-677 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| XLCare Pharmaceuticals, Inc.20 mg, 40 mg · NDC 72865-229, 72865-230 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| American Health Packaging40 mg · NDC 60687-767 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.40 mg per 10 mL · NDC 83634-751 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.20 mg, 40 mg · NDC 62135-533, 62135-534 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc. Pantoprazole Sodium40 mg, 40 mg per 10 mL · NDC 72572-553, 72572-550 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Edenbridge Pharmaceuticals LLC.40 mg · NDC 42799-952 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc. Pantoprazole Sodium40 mg · NDC 0143-9300, 0143-9284 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.20 mg, 40 mg · NDC 62175-180, 62175-618, 62175-617 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.20 mg, 40 mg · NDC 0378-6688, 0378-6689 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Piramal Critical Care Inc.40 mg per 10 mL · NDC 66794-258 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Quallent Pharmaceuticals Health LLC20 mg, 40 mg · NDC 82009-010, 82009-011 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals40 mg per 10 mL · NDC 25021-751 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.40 mg per 10 mL · NDC 0781-3232, 0781-3480 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wockhardt Limited20 mg, 40 mg · NDC 55648-433, 55648-434 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pantoprazole 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:
50090-1415,50090-5361,50090-5793,50090-3095+5 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0406,80425-0085,80425-0179,80425-0278+3 - Aidarex Pharmaceuticals LLC:
33261-629 - American Health Packaging:
60687-725,60687-736 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-340,71610-416,71610-481,71610-659+8 - Asclemed USA, Inc.:
76420-668,76420-671,76420-805,76420-669+2 - AvPAK:
50268-636,50268-585,50268-639,50268-727 - Avera McKennan Hospital:
69189-0841 - Bryant Ranch Prepack:
71335-0291,71335-1572,71335-1165,72162-1746+3 - Cardinal Health 107, LLC:
55154-4346,55154-2645,55154-4232,55154-7477+7 - Coupler Enterprises Inc.:
67046-535,67046-534,67046-536 - Coupler LLC:
67046-0347,67046-0789,67046-0155,67046-0536 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-475,70934-441,70934-145,70934-203 - Direct Rx:
61919-635,61919-134,61919-806,72189-112+4 - Fusion Pharmaceuticals LLC:
70332-300,70332-301 - Golden State Medical Supply, Inc.:
51407-612,51407-613 - Hawaii Repack, Inc.:
85534-0062,85534-0027,85534-0028,85534-0061 - Lake Erie Medical DBA Quality Care Products LLC:
83008-034 - Major Pharmaceuticals:
0904-7458,0904-6870,0904-6474 - Medsource Pharmaceuticals:
45865-622,45865-130,45865-785,45865-676+1 - Mylan Institutional Inc.:
51079-051 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8113,0615-7629 - Northwind Pharmaceuticals:
51655-744,51655-075,51655-797 - NuCare Pharmaceuticals.Inc.:
68071-2891,68071-5053,68071-2285,68071-3776+10 - PD-Rx Pharmaceuticals, Inc.:
72789-268,72789-086 - Phoenix RX LLC:
85509-1332,85509-1636 - Physicians Total Care, Inc.:
54868-4786,54868-6038,54868-4271,54868-5846 - Preferred Pharmaceuticals, Inc..:
68788-8505,68788-8644 - Proficient Rx LP:
63187-831,63187-837,63187-974,63187-938+1 - QPharma, Inc.:
42708-104,42708-180,42708-185 - RPK Pharmaceuticals, Inc.:
53002-1700,53002-2419,53002-1419 - ReadyMeds:
64205-181 - Rebel Distributors Corp..:
21695-771,21695-108,42254-124 - RedPharm Drug. Inc.:
67296-1187,67296-1230,67296-0029,67296-2047+2 - Remedyrepack Inc.:
70518-1788,70518-0860,70518-1298 - RxChange Co.:
33358-536 - Safecor Health, LLC:
48433-081 - Sportpharm LLC:
85766-224,85766-225 - St. Mary's Medical Park Pharmacy:
60760-574,60760-679 - Stat Rx USA:
16590-635,16590-939 - State of Florida DOH Central Pharmacy:
53808-0935,53808-1081,53808-1123,53808-0934+4 - Unit Dose Services:
50436-0096,50436-8102,50436-0712,50436-0429 - Unit Dose Solutions, Inc.:
87441-065,87441-066
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations - Mar 26, 2026 · Class II · Hetero Labs Limited (Unit V)
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." - Sep 5, 2023 · Class II · Be Pharmaceuticals Ag
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. - Mar 14, 2023 · Class II · Hetero USA Inc
CGMP Deviations: Discoloration - Jul 25, 2022 · Class II · Sun Pharmaceutical Industries Inc
Discoloration - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Apr 11, 2022 · Class II · Torrent Pharma Inc
CGMP deviations: tablets cracking - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Feb 5, 2021 · Class III · Sun Pharmaceutical Industries Inc
Failed Impurity/Degradation Specifications - Dec 4, 2017 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass - Dec 16, 2016 · Class III · Aurobindo Pharma USA Inc
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. - Nov 22, 2016 · Class III · Pfizer Inc.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.