S.A.L.F. is authorized to produce, package and test unsterilized injectable solutions in their final container.
• Authorization with Determination no. aM – 205/2017 of 23/11/2017 for the production of MEDICINES in the following pharmaceutical forms:
1. Sterile products
2. Terminally sterilized products
3. Large volume liquids
4. Small volume liquids
• Marketing authorization for individual pre-packaged drugs, prepared industrially, other than proprietary medicinal products (Ministerial Decree of 08/11/1993 published in the ordinary supplement to the Official Gazette no. 295 of 17/12/1993 and subsequent revisions)
• Authorization for the use of Narcotic Drugs
• License for Drugs Precursors
• Authorization for the production of pre-packaged drugs for veterinary use
• Exclusive authorization to export: Indigo carmine 40 mg 5 ml
• Authorization for the production, testing and final packaging also in factories belonging to third parties.
• CE certification (Approval of the Assurance System of Quality, Manufacturing and Sterilization) by Istituto Superiore Sanità (National Institute of Health), Notified Body no. 0373.
In addition to producing drugs for which it holds a Marketing Authorization (MA), on hospital medical demand, according to Article. 5 of Legislative Decree 219/06, S.A.L.F. produces a range of sterile and injectable drugs not available on the Italian market, whose active ingredients are described in a EU pharmacopoeia or contained in a drug marketed in a EU country.