CMOs Beware of GDUFA Fees

CMOs Beware of GDUFA Fees

Berkshire Sterile Manufacturing by Andrea Wagner, PhD     The FDA instituted a new program in 2013, to charge API and finish drug product facilities who manufacture generic drugs an…
BSM’s Amazing Steam Sterilizer

BSM’s Amazing Steam Sterilizer

Berkshire Sterile Manufacturing     BSM’s FEDEGARI autoclave has the capability to terminally sterilize syringes, bags, vials and ampules with a 20,000 unit load capacity.  The autoclave has internal heat…