Prescription drug
Where is 4-Hydroxycyclophosphamide made?
25 companies sell it under their own name. Their labels name 12 factories in India, the United States, Germany, China and Switzerland.
India 4United States 3Germany 2China 2Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories. Cyclophosphamide1 g per 50 mL, 2 g per 100 mL, 200 mg per 1 mL, 500 mg per 25 mL · NDC 68001-443, 68001-695, 68001-444 +6 | Avyxa GmbHMakes it, tests it, packages it and sterilizes it | Barbengo, Switzerland | Problems found, fixed voluntarilyOct 2024 |
| Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 | |
| Simtra Deutschland GmbHMakes it, tests it, packages it, labels it and sterilizes it | Halle/Westfalen, Germany | Serious problems, FDA actionSep 2025 | |
| Alembic Pharmaceuticals Inc.25 mg, 50 mg · NDC 62332-618, 62332-619 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited25 mg, 50 mg · NDC 46708-618, 46708-619 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Amneal Pharmaceuticals25 mg, 50 mg · NDC 69238-1561, 69238-1562 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| AuroMedics Pharma LLC Cyclophosphamide1 g per 5 mL, 2 g per 10 mL, 500 mg per 2.5 mL · NDC 55150-271, 55150-272, 55150-270 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Avyxa Pharma, LLC Cyclophosphamide, Frindovyx1 g per 2 mL, 2 g per 4 mL, 500 mg per 1 mL · NDC 83831-117, 83831-120, 83831-118 +3 | Dr.reddy's Laboratories LimitedMakes it, tests it and packages it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Baxter Healthcare Corporation Cyclophosphamide1 g per 50 mL, 2 g per 100 mL, 25 mg, 50 mg, 200 mg per 1 mL, 500 mg per 25 mL · NDC 10019-936, 10019-944, 10019-939 +13 | Baxter Deutschland GmbHMakes the active ingredient | Bielefeld, Germany | Problems found, fixed voluntarilyMay 2025 |
| Cipla USA., Inc.25 mg, 50 mg · NDC 69097-516, 69097-517 | Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Fresenius Kabi USA, LLC1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 65219-131, 65219-133, 65219-135 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Makes it, makes the active ingredient, tests it and packages it | Lianyungang, China | Problems found, fixed voluntarilyApr 2026 |
| Hainan Poly Pharm. Co., Ltd.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 14335-471, 14335-472, 14335-470 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Hikma Pharmaceuticals USA Inc. Cyclophosphamide25 mg, 50 mg · NDC 0054-0382, 0054-0383 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Hisun Pharmaceuticals USA Inc.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 42658-033, 42658-034, 42658-035 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Slate Run Pharmaceuticals, LLC.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 70436-106, 70436-107, 70436-105 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Amneal Pharmaceuticals LLC1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 70121-1239, 70121-1240, 70121-1238 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 83634-206, 83634-207, 83634-205 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Bamboo US Bidco LCC1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 83703-550, 83703-551, 83703-549 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 72572-085, 72572-083, 72572-087 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc. Cyclophosphamide200 mg per 1 mL · NDC 75907-191, 75907-190, 75907-189 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Epic Pharma, LLC1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 42806-902, 42806-903, 42806-901 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.200 mg per 1 mL · NDC 14789-126, 14789-125 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 16714-857, 16714-858, 16714-859 | The label doesn't name the factory. Plants this company names for other drugs | ||
| OPKO Pharmaceuticals LLC25 mg, 50 mg · NDC 70301-2013, 70301-2015 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 25021-248, 25021-249, 25021-247 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Cyclophosphamide1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL, 500 mg per 5 mL, 1000 mg per 10 mL, 2000 mg per 20 mL · NDC 0781-3244, 0781-3529, 0781-3255 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.1 g per 50 mL, 2 g per 100 mL, 500 mg per 25 mL · NDC 39822-0255, 39822-0260, 39822-0250 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Sep 5, 2025 · Class II · Sandoz Inc
cGMP deviations: Temperature excursion during transportation. - Apr 2, 2024 · Class III · X-Gen Pharmaceuticals Inc. · 2 recall notices
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '2…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.