Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing
140 Front Avenue SW, Grand Rapids, MI 49504, USA
Overview
Gram is a sterile injection CDMO based in Grand Rapids, Michigan that focuses on sterile filling of liquids and lyophilized vials, syringes, cartridges. It has 5 GMP plants (about 450,000 sq ft), 3 of which are designed according to Annex 1; the filling lines are all equipped with isolator technology. Sterile Filling Facility Two is equipped with a groninger 10-head syringe/cartridge filling line (SKAN isolator), with a cartridge specification of 1.5-20 mL, with an annual capacity of more than 50 million bottles/syringes; Facility One has an annual capacity of more than 80 million vials and more than 10 million syringes/cartridges, and is equipped with an IMA lyophilizer. In 2026, it was announced that $100 million would be invested in the expansion of the fifth filling line and plant to strengthen the production capacity of commercial-grade prefilled syringes and cartridges. Have FDA/EU approved production lines, controlled substances and formulation capabilities (up to 1,000 L).