API producer Labochim
The inspection covered two pre-approvals for New Drug Applications (NDAs) and one approval for Abbreviated New Drug Applications (ANDA).
Labochim is routinely inspected by various regulatory agencies, including AIFA (the Italian Ministry of Health). The most-recent FDA inspection was November 19-22, 2007.
This has been a busy year for the Infa Group. Sister company Sifavitor also was inspected by US FDA in March, 2009. The inspection covered seven pre-approvals for ANDAs. The Sifavitor facility in Lodi, Italy was also found acceptable.
Regulatory compliance is a strategic focus at Labochim and all facilities within the Infa Group. Our history of successful inspections since the 1970’s has contributed to the Group’s growth worldwide.