manufactured · input

Water for Injection (WFI)

Highly purified water produced on-site by multi-effect distillation or membrane-based purification. Must meet USP <1231> and EP 0169 standards: conductivity <1.3 μS/cm at 25°C, total organic carbon <500 ppb, endotoxin <0.25 EU/mL, no viable organisms. WFI systems are facility-specific assets — cannot be outsourced.

5

Source countries

4

Companies

1

Goods affected

0

Claims on record

What depends on it

Goods that need this input

1 essential American goods rely on water for injection (wfi) somewhere upstream in their supply chain.

Where it comes from

Source countries

Share of global supply, by country.

CountryShare of supply
USUnited States30%
CNChina20%
DEGermany20%
INIndia12%
PRPuerto Rico5%

Who makes it

Supplier companies

4 companies produce water for injection (wfi).

GEA Group AG(G1A.DE)

HQ DE40% share

GEA Group AG (Düsseldorf Germany; DAX: G1A; ~€5.4B revenue) is a global food and dairy processing equipment giant with a major IQF/spiral freezer division under GEA Refrigeration Technologies. GEA makes the GEA Zip Freezer (spiral design) and tunnel-type industrial freezers using mechanical ammonia refrigeration — typically for large-scale vegetables, seafood, and prepared food processing. GEA competes directly with JBT Frigoscandia in mechanically-refrigerated IQF equipment for high-throughput food plants. GEA's food processing division also includes dairy separators, homogenizers, and brewing equipment. Founded as Metallgesellschaft refrigeration unit; GEA is the dominant European manufacturer of large ammonia-refrigerated food processing equipment and IQF freezers.

Baxter International Inc.(BAX)

HQ US35% share

Dominant US producer of peritoneal dialysis solutions (Dianeal, Extraneal, Physioneal) and major HD consumables manufacturer. The North Cove, NC facility (flooded by Hurricane Helene, September 2024) produced ~60% of US IV fluids and a critical share of PD solution. Baxter's kidney care business was spun out as Vantive in 2024.

Fresenius Kabi AG

HQ DE25% share

Fresenius Kabi AG (Bad Homburg, Hessen Germany; subsidiary of Fresenius SE & Co. KGaA; ~€9B revenue) is one of the two largest US suppliers of injectable opioid vials for hospital use. Fresenius Kabi's US pharmaceutical manufacturing includes morphine sulfate injection, fentanyl citrate injection, and hydromorphone HCl injection. US manufacturing sites: Wilson NC (large sterile fill-finish campus) and Grand Island NE. Fresenius Kabi was one of the companies hit by the FDA's heightened enforcement of injectable GMP standards in the 2010s. The Wilson NC facility received FDA Warning Letters for sterile manufacturing deficiencies — a pattern common across the injectable pharmaceutical industry. Fresenius Kabi also produces IV fluids, parenteral nutrition, and biosimilars from its US sites, making it a broad-spectrum hospital injectable supplier whose opioid vial lines compete for the same cleanroom capacity as other critical parenteral products.

MECO Company

HQ US20% share

American pharmaceutical water distillation systems manufacturer (Mandeville, Louisiana); specialized in vapor compression (VC) and multi-effect (ME) distillation systems for WFI production. MECO is the leading US manufacturer of WFI distillation equipment for pharmaceutical manufacturing — less well-known than GEA (German market leader) but MECO systems are installed at major US pharmaceutical sites including Baxter and ICU Medical (Hospira). MECO also produces shipboard water distillation systems for the US Navy — the same distillation engineering that makes WFI for hospital IV bags also desalinates seawater for naval vessels.