Leukocyte Growth Factor
Where is Filgrastim made?
8 companies sell it under their own name and 1 repackager rebottle it. Their labels name 5 factories in the United States, India and Croatia.
United States 3India 1Croatia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Nivestym300 ug per 0.5 mL, 300 ug per 1 mL, 480 ug per 0.8 mL, 480 ug per 1.6 mL · NDC 0069-0291, 0069-0293, 0069-0292 +1 | Hospira Zagreb d.o.o.Makes it, makes the active ingredient, tests it, packages it and labels it | Prigorje Brdovecko, Croatia | Problems found, fixed voluntarilyJul 2024 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Accord BioPharma Inc. Filkri300 ug per 0.5 mL, 480 ug per 0.8 mL · NDC 69448-008, 69448-009 | Intas Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Ahmedabad, India | Not inspected on record |
| Amneal Pharmaceuticals LLC Releuko300 ug per 0.5 mL, 300 ug per 1 mL, 480 ug per 0.8 mL, 480 ug per 1.6 mL · NDC 70121-1568, 70121-1569, 70121-1570 +1 | Kashiv BioSciences, LLCMakes it and tests it | Chicago, IL, United States | Problems found, fixed voluntarilyJun 2024 |
| Cipla USA., Inc. Nypozi300 ug per 300 ug, 480 ug per 480 ug · NDC 69097-430, 69097-429 | Tanvex BioPharma USA, IncMakes it | San Diego, CA, United States | Not inspected on record |
| Amgen Inc Neupogen300 ug per 0.5 mL, 300 ug per 1 mL, 480 ug per 0.8 mL, 480 ug per 1.6 mL · NDC 55513-924, 55513-530, 55513-209 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Zarxio300 ug per 0.5 mL, 480 ug per 0.8 mL · NDC 61314-318, 61314-326 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tanvex BioPharma USA, Inc. NYPOZItxid300 ug per 300 ug, 480 ug per 480 ug · NDC 72374-101, 72374-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc. Granix300 ug per 0.5 mL, 300 ug per 1 mL, 480 ug per 0.8 mL, 480 ug per 1.6 mL · NDC 63459-910, 63459-918, 63459-912 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Filgrastim 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.
- Physicians Total Care, Inc.:
54868-5020,54868-2522,54868-3050
Recalls
- Feb 27, 2025 · Class II · Amgen, Inc. · 2 recall notices
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. - Jan 10, 2025 · Class II · Teva Pharmaceuticals USA, Inc
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.