Pioneers in Lyophilization

Lyophilized Bulk Sterile API is one of Mac-Chem's three API segments, alongside Oncology API and General API. It covers active pharmaceutical ingredients manufactured, freeze-dried, and released in sterile bulk form for formulation partners who require this dosage-form starting material. Mac-Chem markets its lyophilization work under the line "Pioneers in Lyophilization."

The Boisar plant operates multiple lyophilizers, including 140 L and 400 L units, dedicated to freeze-drying sterile bulk API. This equipment sits alongside the plant's 8 stainless-steel and 6 glass-lined reactors, and its steam and dry-heat sterilizers.

Lyophilized Bulk Sterile API manufacturing, including cytotoxic oncology molecules, runs under Mac-Chem's Cat III & IV containment facility, with glove-box technology purpose-built for cytotoxic substances, and under fully automated, GAMP-compliant control.