AMRI has signed an agreement to acquire Prime European Therapeuticals S.p.A., also known as Euticals, for approximately $358 million.

Euticals is a privately held company headquartered in Lodi, Italy, specializing in custom synthesis and the manufacture of active pharmaceutical ingredients (APIs). It operates a network of API facilities primarily in Italy, Germany, the U.S. and France.

“The acquisition of Euticals will provide us an established custom synthesis presence in Europe and will further build on our expertise in complex APIs, positioning AMRI as a preeminent provider of contract research, development and manufacturing services to the pharmaceutical industry,” said William Marth, president and chief executive officer, AMRI. “Euticals’ expertise with niche and high barrier to entry technologies and products, including certain tetracyclines, monobactams, sterile and fermented APIs and controlled substances, will be a tremendous asset to us. Additionally, Euticals’ large base of over 400 customers will provide us with a number of new large pharma, biotech and generics partners, further extending our global reach and diversifying our revenue.”

Margalit Fine, Euticals’ chief executive officer and former head of European API at Teva, will be leading Euticals’ operations as a senior executive for the combined company.

The deal expands AMRI’s capabilities in custom and complex APIs; provides it with an established European custom synthesis presence; expands its expertise in multiple areas including sterile API, steroids, generics, fermentation, controlled substances and monobactams; and provides an API portfolio that includes 50 active U.S. Drug Master Files (DMFs), 17 EU Certificates of Suitability (COS) or Compliance with the European Pharmacopeia (CEP), 13 Japanese DMFs and 6 South Korean DMFs; with several APIs having filings in more than one of these areas and over two dozen other international filings.

With 75% of revenue outside North America, Euticals opens up many new markets for AMRI.