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Applied Pharmaceutical Innovation vs Optimus Drugs Private Limited

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CategoryApplied Pharmaceutical InnovationOptimus Drugs Private Limited
Listed sitebothcdmo
SummaryEdmonton-based not-for-profit offering integrated CDMO services in sterile fill-finish, oral solid dosage, topical application, and highly potent controlled substance manufacturing. Also provides CRO research, regulatory and quality, and clinical and quantitative support.Leading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities.
Services
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Oral Solid Dosage Manufacturing
  • Topical & Semi-Solid Manufacturing
  • Small Molecule Development & Manufacturing
  • Controlled Substance Manufacturing
  • HPAPI Manufacturing (High-Potency)
  • Formulation Development
  • CMC Regulatory Submission Support
  • Quality Control Testing
  • CMC Analytical Development
  • Topical & Semi-Solid Manufacturing
  • Quality Control Testing
  • Stability Testing & Storage
  • API Synthesis & Manufacturing
  • Small Molecule Development & Manufacturing
  • Process Development
  • Formulation Development
  • Oral Solid Dosage Manufacturing
  • Technology Transfer
  • CMC Regulatory Submission Support
Modalities
  • Small Molecule
  • Small Molecule
IndicationsData not yet provided.
  • Neurology
  • Metabolic
  • Cardiovascular
  • Infectious Disease
Locations
  • Headquarters, Edmonton, Alberta, Canada
  • Calgary, Calgary, Alberta, Canada
  • Headquarters, India
CertificationsData not yet provided.
  • US FDA · Identifier: FDA approval (FDF facility)
  • EMA · Identifier: EU GMP approval
  • ANVISA · Identifier: ANVISA audit clearance (Unit 1)
  • WHO · Identifier: WHO GMP audit clearance
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.