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Gilero vs Kindeva Drug Delivery

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CategoryGileroKindeva Drug Delivery
Listed sitecdmocdmo
SummaryGilero provides design, development, and contract manufacturing services for medical devices, drug delivery systems, and combination products, with global manufacturing facilities in the U.S., Mexico, Europe, and Asia.Purpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities.
Services
  • Combination Product Assembly & Final Packaging
  • CMC Analytical Development
  • Technology Transfer
  • Formulation Development
  • Process Development
  • Formulation Development
  • Process Development
  • CMC Analytical Development
  • Technology Transfer
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Inhalation & Nasal Dosage Manufacturing
  • Topical & Semi-Solid Manufacturing
  • Stability Testing & Storage
  • Quality Control Testing
  • CMC Regulatory Submission Support
  • Combination Product Assembly & Final Packaging
ModalitiesData not yet provided.Data not yet provided.
IndicationsData not yet provided.Data not yet provided.
Locations
  • Headquarters / Design & Development, Pittsboro, NC, USA
  • Manufacturing, Tijuana, B.C., Mexico
  • Business Development, Chicago, IL, USA
  • Headquarters, Woodbury, Minnesota, United States
  • Bridgeton, Bridgeton, Missouri, United States
  • Brentwood, Brentwood, Missouri, United States
  • Maryland Heights, Maryland Heights, Maryland, United States
  • Northridge, Northridge, California, United States
  • Union City, Union City, California, United States
  • Lexington, Lexington, Kentucky, United States
  • Germantown, Germantown, Maryland, United States
  • Loughborough, Loughborough, England, United Kingdom
  • Clitheroe, Clitheroe, England, United Kingdom
  • Bridgeton, Bridgeton
CertificationsData not yet provided.
  • FDA · Identifier: cGMP (CFR 210, 211, 820; 21 CFR Part 4)
  • ICH · Identifier: ICH Q1A through Q10
  • EU · Identifier: Annex 1 compliance
  • ISO · Identifier: ISO certifications
  • FDA · Identifier: cGMP (CFR 210, CFR 211, CFR 820, 21 CFR Part 4)
  • EMA · Identifier: Annex 1 Compliance
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.