About Singota
  • Singota’s facility is in Bloomington, IN
  • We are ~90 minutes from major FedEx & UPS hubs
  • Serving 200+ clients with active projects
    • Large Pharma
    • Virtual Pharma
    • Consulting Firms
    • Animal Health
Supply Chain
  • 15-25°C
  • 2-8°C
  • -20°C
  • -80°C
  • Hazardous storage
  • Open bonded warehouse location in Switzerland
  • We offer temperature, relative humidity, and differential pressure monitoring where applicable
  • We do not offer liquid nitrogen, cell bank, human tissues, beta-lactams, or cephalosporins storage currently
  • Yes, Singota is FDA registered to handle storage of controlled substances (Scheduled CIII-CV).
  • FDA Registration
  • EU GMP Certificate
  • Drug Distributor Accreditation
  • Japanese PMDA
  • DEA Licenses (Analytical, Distributor, Manufacturing)
  • 3PL Licenses
  • Singota is a ~72,000 ft² facility with a range of storage options. We have domestic and international partnerships to meet our client’s logistics and storage needs. Please contact us for specific open capacity and capability.
  • Single use-disposable product contact items
  • Utilize electronic documentation for weigh & dispense
  • Sampling and Dispensing services cover:
    • Powders and liquids
    • Flammable, toxic, and potent materials
    • Light, humidity, and static sensitive materials
Aseptic Manufacturing
  • Cytiva (formerly Vanrx) SA25 workcell, an automated filling, stoppering, and capping process integrated within a gloveless isolator
  • No human exposure to Grade A areas, no human intervention
  • Pre-sterilized single use flow path,  component sterilization
  • Pre-sterilized, nested, Read-to-Use (RTU) components
    • Syringes: 1mL Long, 1mL – 3mL standard
    • Vials: 2R-30R
    • Cartridges: 1.5mL
    • We do not fill bags or bottles currently
  • Aqueous based, parenteral aseptic filling
  • We have experience from Pre-clinical to Phase 3
  • Batch Sizes: <100 to 10,000 units
  • Fill volumes: We have flexibility of formats and fill volumes
  • We have a flexible schedule; We can work with our clients to meet their timeline(s).
Development and Testing

Yes

  • Yes
  • Sterility Testing USP <71>
  • Bacterial Endotoxin Testing USP <85>
  • Microbial Enumeration/Bioburden USP <61>
  • Specified Microorganism Testing USP <62>
  • Yes, ICH storage conditions and excursion capabilities
  • For full list of services, please download our Service Offering fact sheet
  • API and Drug Product release testing
  • Raw material testing
  • Infusion and material compatibility studies
  • Container closure integrity testing (CCIT)
  • Reconstitution studies
  • Post packaging ID
Finishing Services
  • Yes, we support development and clinical trial labeling and kitting needs.
  • Services we offer:
    • Labeling/De-labeling
    • Re-labeling
    • Kitting
    • Blinded
Quality Status
  • QOH – Quantity on hand / released status; this is the only status that permits material transactions (aliquot, ship, etc.)
  • QC – Quarantine status
  • QR – Quality hold status
  • REJ – Reject status; this is for materials deemed unacceptable for use and/or destined for disposal.
  • RESEARCH – Non-GMP status; this status indicates the material is only for non-GMP/not for human use.
  • RETAIN – Retention status; designates the material is part of the retention program at Singota.
  • STAB – Stability status; designates the material is part of a stability study at Singota.

FAQ