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Grand River Aseptic Manufacturing vs Singota Solutions

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CategoryGrand River Aseptic ManufacturingSingota Solutions
Listed sitecdmocdmo
SummarySterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.Bloomington-based CDMO specializing in aseptic filling of small-volume parenterals (vials, syringes, cartridges), formulation development, QC testing, and supply chain management with GMP-compliant operations.
Services
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Lyophilization (Freeze Drying)
  • Quality Control Testing
  • Secondary Packaging & Labeling
  • Serialization & Track-and-Trace
  • Stability Testing & Storage
  • CMC Analytical Development
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Controlled Substance Manufacturing
  • Vaccine Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Biologics Development & Manufacturing
  • API Synthesis & Manufacturing
  • Small Molecule Development & Manufacturing
  • Formulation Development
  • CMC Analytical Development
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Quality Control Testing
  • Stability Testing & Storage
  • Cold-Chain Storage & Logistics
  • Lyophilization (Freeze Drying)
  • Technology Transfer
  • Secondary Packaging & Labeling
Modalities
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Vaccine
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Oligonucleotide
  • Peptide
  • Vaccine
IndicationsData not yet provided.Data not yet provided.
Locations
  • Headquarters, Grand Rapids, Michigan, United States
  • Headquarters
  • Headquarters, Bloomington, Indiana, USA
  • Headquarters, Bloomington, Indiana, United States
Certifications
  • GMP · Identifier: Five GMP manufacturing facilities
  • Annex 1 · Identifier: Three facilities designed and qualified with Annex 1 revisions
  • GMP · Identifier: Five GMP manufacturing facilities; three Annex 1 compliant
  • FDA · Identifier: GMP
  • EMA · Identifier: Annex 1
  • GMP · Identifier: Five GMP manufacturing facilities (three Annex 1 compliant)
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.