FIS is authorized to manufacture veterinary APIs and are regularly inspected by the Italian Ministry of Health – Veterinary Division as well as many other international authorities, including the USFDA, PMDA, KFDA, and Anvisa. FIS offers contract manufacture of Animal Health APIs as well as generic veterinary APIs.
Our portfolio encompasses the following classes of veterinary APIs: ecto- and endoparasiticides, sex hormones, metabolic hormones, antibacterials, gastrointestinal protectors, psychotropics, and anti‑inflammatory drugs.
We provide full support for registrations (DMF/VMF) supported by our long-term experience. Our molecules are registered in the EU and the US, as well as other countries worldwide, most with a CEP.
Contract-manufactured Animal Health APIs are managed by an integrated team which includes experts from our R&D, Analytical, QA, Procurement, Engineering, and Industrialization departments.
In addition, we have a dedicated team working to develop new generic Animal Health APIs. Team activities range from route scouting, FTO assessment, and process development, to the scale-up activities required to bring the product to process validation and commercial batches.
FIS is continuing to enhance their capability and capacity by building a dedicated suite for veterinary APIs.