SQ Innovation Secures Long-Term API Supply from FIS for Lasix ONYU

  • SQ Innovation has entered a strategic supply agreement with FIS to secure pharmaceutical-grade furosemide API for its products.
  • The agreement supports production of Lasix ONYU and future pipeline development across the United States, Europe, and global markets.

SQ Innovation has announced a strategic supply agreement with F.I.S. – Fabbrica Italiana Sintetici S.p.A. to secure long-term access to pharmaceutical-grade furosemide active pharmaceutical ingredient (API). The agreement supports the continued production and global expansion of the company’s drug-device combination product, Lasix ONYU.

Under the terms of the agreement, FIS will supply furosemide API to support manufacturing of Lasix ONYU, which was approved by the U.S. Food and Drug Administration in 2025 for at-home treatment of edema in adult patients with heart failure. The partnership also includes provisions to support SQ Innovation’s development pipeline and geographic expansion plans.

FIS, based in Italy, provides API development and manufacturing services and will act as a key supply partner in ensuring consistent availability of the ingredient. The agreement includes certain exclusivity provisions, although further details were not disclosed.

The collaboration is intended to strengthen SQ Innovation’s supply chain and support reliable production of its therapies across multiple regions, including the United States and Europe. The companies stated that securing a consistent API supply is critical for maintaining product availability and supporting future growth.

“Securing a reliable supply of high-quality furosemide API is critical to our mission of providing innovative heart failure treatment options that aim to provide an alternative to hospitalizations.”

Pieter Muntendam, Founder, President and CEO of SQ Innovation
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