Leukocyte Growth Factor
Where is Pegfilgrastim made?
10 companies sell it under their own name. Their labels name 7 factories in the United States, India, the United Kingdom, Italy and Croatia.
United States 2India 2United Kingdom 1Italy 1Croatia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC Stimufend6 mg per 0.6 mL · NDC 65219-371 | FUJIFILM Diosynth Biotechnologies UK LtdMakes the active ingredient and tests it | Billingham, United Kingdom | Problems found, fixed voluntarilyMar 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Merck Biodevelopment, MartillacMakes the active ingredient and tests it | Location not on file | Not inspected on record | |
| Merck Serono SpaMakes it | Modugno (loc. frazione Zona Industriale), Italy | Problems found, fixed voluntarilySep 2025 | |
| Northstar Rx LLC. Stimufend6 mg per 0.6 mL · NDC 72603-402 | FUJIFILM Diosynth Biotechnologies UK LtdMakes the active ingredient and tests it | Billingham, United Kingdom | Problems found, fixed voluntarilyMar 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Merck Biodevelopment, MartillacMakes the active ingredient and tests it | Location not on file | Not inspected on record | |
| Merck Serono SpaMakes it | Modugno (loc. frazione Zona Industriale), Italy | Problems found, fixed voluntarilySep 2025 | |
| Amneal Pharmaceuticals LLC Fylnetra6 mg per 0.6 mL · NDC 70121-1627 | Kashiv BioSciences, LLCMakes it and tests it | Chicago, IL, United States | Problems found, fixed voluntarilyJun 2024 |
| Biocon Biologics Inc. Fulphila6 mg per 0.6 mL · NDC 83257-005 | Biocon Biologics LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyJul 2024 |
| Lupin Pharmaceuticals, Inc. Armlupeg6 mg per 0.6 mL · NDC 70748-273 | Lupin LimitedMakes it, tests it and packages it | Pune, India | Not inspected on record |
| Pfizer Laboratories Div Pfizer Inc Nyvepria6 mg per 0.6 mL · NDC 0069-0324 | 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 |
| Accord BioPharma Inc. Udenyca6 mg per 0.6 mL · NDC 69448-025, 69448-026, 69448-027 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amgen Inc Neulasta4 mg per 0.4 mL, 6 mg per 0.6 mL · NDC 55513-099, 55513-192, 55513-190 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Coherus Oncology, Inc. Udenyca6 mg per 0.6 mL · NDC 70114-101, 70114-120, 70114-130 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Ziextenzo6 mg per 0.6 mL · NDC 61314-866 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jan 16, 2026 · Class I · McKesson
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.