Facility
Odin’s location in Somerset, New Jersey includes over 75,000 square feet of warehousing, office, and laboratory space originally built by Merck Pharmaceuticals. This facility is currently being upgraded to an ultra-modern sterile liquid and lyophilization processing plant that will fill injectable and ophthalmic dosage forms utilizing the most innovative high velocity and high-pressure equipment. Plans are also being executed to expand the facility with an additional 40,000 square feet of shell coverage to be used for distribution and laboratories.
Compliance
As a Research and Development organization, Odin is compliant and/or registered with all regulatory organizations, including but not limited to:
- Food and Drug Administration
- New Jersey Department of Health Consumer and Environmental Health Service
- Environmental Protection Agency
- Occupational Safety Health and Agency
- New Jersey Department of Environmental Health
- New Jersey Department of Labor and Workforce Department
As the company develops manufacturing capabilities, it anticipates timely auditing and issuance of cGMP compliance by the FDA. Executive leadership has remained compliant with the agency through many past audits with previous companies, including several audits of aseptic processing operations.
Research & Development
Odin Pharmaceuticals is actively developing several difficult-to-develop and difficult-to-manufacture products. The company’s product focus spans multiple dosage forms utilizing aseptic processing and terminal sterilization:
- Wet Vials
- Lyophilized Vials
- Pre-filled Syringes
- Ophthalmic Droppers
- Intravenous Bags
The firm’s products incorporate advanced pharmaceutical technologies, including:
- Colloids and Emulsions
- Microsuspensions and Nanosuspensions
- Microspheres
- Insoluble Salts and Drug Complexes
- In Situ Gelling Systems
- Liposomes and Lipid Complexes
The formulation team focuses heavily on preformulation, analysis, and scale-up.
Commercialization
Odin plans to market its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies. The firm has relationships with all major customers. Below is a selected list of accounts:
