Antifibrinolytic Agent
Where is Tranexamic Acid made?
32 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 18 factories in India, the United States, Norway, China and Belgium.
India 13United States 2Norway 1China 1Belgium 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited10 mg per 1 mL, 100 mg per 1 mL · NDC 68083-613, 68083-160 | 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 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 g per 10 mL, 100 mg per 1 mL · NDC 23155-524, 23155-166, 23155-909 +1 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Milla Pharmaceuticals Inc.100 mg per 1 mL · NDC 71357-017, 71357-018 | Hunan Dongting Pharmaceutical Co., Ltd.Makes the active ingredient | China | No problems foundMay 2024 |
| Immacule Lifesciences Private LimitedMakes it, tests it, packages it and labels it | Solan, India | Serious problems, FDA actionSep 2025 | |
| Provepharm Inc.100 mg per 1 mL · NDC 81284-611, 81284-612 | Hunan Dongting Pharmaceutical Co., Ltd.Makes the active ingredient | China | No problems foundMay 2024 |
| Immacule Lifesciences Private LimitedMakes it, tests it, packages it and labels it | Solan, India | Serious problems, FDA actionSep 2025 | |
| Advagen Pharma Ltd.650 mg · NDC 72888-178 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Amneal Pharmaceuticals Private Limited10 mg per 1 mL · NDC 80830-2329 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 |
| Armas Pharmaceuticals Inc.100 mg per 1 mL · NDC 72485-107, 72485-510 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| AuroMedics Pharma LLC100 mg per 1 mL · NDC 55150-188 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Aurobindo Pharma Limited650 mg · NDC 59651-839 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Cadila Healthcare Limited650 mg · NDC 70771-1989 | Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record |
| Caplin Steriles Limited100 mg per 1 mL · NDC 65145-106 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Dr. Reddy's Laboratories Inc.650 mg · NDC 75907-309 | Steril-Gene Life Sciences Private LimitedMakes it, tests it and packages it | Puducherry, India | Serious problems, FDA actionAug 2026 |
| Emcure Pharmaceuticals Limited1 g per 10 mL · NDC 14593-318 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Exela Pharma Sciences, LLC Tranexamic Acid In Sodium Chloride10 mg per 1 mL · NDC 51754-0108 | Exela Pharma Sciences, LLC.Makes it, tests it, packages it and labels it | Lenoir, NC, United States | Serious problems, FDA actionNov 2024 |
| Fresenius Kabi USA, LLC10 mg per 1 mL · NDC 65219-534 | HP Halden Pharma ASMakes it, tests it and packages it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Hp Halden Pharma AS10 mg per 1 mL · NDC 66298-5340 | HP Halden Pharma ASMakes it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Micro Labs Limited100 mg per 1 mL · NDC 42571-189, 42571-314 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Nordic Pharma, Inc.650 mg · NDC 69918-301 | Mikart, LLCMakes it | Atlanta, GA, United States | No problems foundAug 2026 |
| Northstar Rx LLC.100 mg per 1 mL, 650 mg · NDC 72603-387, 72603-818 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Pfizer Laboratories Div Pfizer Inc Cyklokapron100 mg per 1 mL · NDC 0013-1114 | Pfizer Manufacturing Belgium NVMakes it, tests it, packages it and labels it | Puurs-Sint-Amands, Belgium | Problems found, fixed voluntarilyJun 2022 |
| Viona Pharmaceuticals Inc.650 mg · NDC 72578-220 | Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record |
| i3 Pharmaceuticals, LLC650 mg · NDC 72319-028 | Axxelent Pharma Science Private LimitedMakes it, tests it and packages it | Tirupati, India | Not inspected on record |
| ANI Pharmaceuticals, Inc.650 mg · NDC 62559-265 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Actavis Pharma, Inc.650 mg · NDC 0591-3720 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals LLC100 mg per 1 mL · NDC 70121-1398 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.100 mg per 1 mL · NDC 60505-6169 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.10 mg per 1 mL, 100 mg per 1 mL · NDC 83634-403, 83634-401 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Baxter Healthcare Corporation100 mg per 1 mL · NDC 43066-008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC100 mg per 1 mL · NDC 67457-197 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.10 mg per 1 mL · NDC 14789-115 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL, 100 mg per 1 mL · NDC 25021-418, 25021-415 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.100 mg per 1 mL · NDC 39822-1000 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tranexamic 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:
50090-4530 - American Health Packaging:
60687-750 - AvPAK:
50268-772 - Bryant Ranch Prepack:
63629-8599,63629-8838,71335-1981,71335-2695 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1532,51662-1714 - Proficient Rx LP:
82804-208 - Remedyrepack Inc.:
70518-4089
Recalls
- Jun 13, 2023 · Class III · Avkare Llc
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. - Jun 12, 2023 · Class III · Amring Pharmaceuticals Inc
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. - Sep 26, 2022 · Class III · AuroMedics Pharma LLC
Presence of Particulate Matter: Piece of metal found in a vial - Aug 17, 2020 · Class I · Mylan Institutional LLC
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.