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Kindeva Drug Delivery vs MyBiotech GmbH

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CategoryKindeva Drug DeliveryMyBiotech GmbH
Listed sitecdmocdmo
SummaryPurpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities.Germany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products.
Services
  • 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
  • Formulation Development
  • Process Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Lyophilization (Freeze Drying)
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Technology Transfer
  • CMC Regulatory Submission Support
ModalitiesData not yet provided.Data not yet provided.
IndicationsData not yet provided.Data not yet provided.
Locations
  • 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
  • Headquarters, Überherrn, Saarland, Germany
Certifications
  • 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
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.