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CMC Pharmaceuticals, Inc. vs Optimus Drugs Private Limited

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CategoryCMC Pharmaceuticals, Inc.Optimus Drugs Private Limited
Listed sitecdmocdmo
SummaryCMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.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
  • Formulation Development
  • Process Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Technology Transfer
  • CMC Regulatory Submission Support
  • API Synthesis & Manufacturing
  • Small Molecule Development & Manufacturing
  • Controlled Substance Manufacturing
  • HPAPI Manufacturing (High-Potency)
  • 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.
  • Metabolic
  • Cardiovascular
  • Neurology
  • Infectious Disease
Locations
  • Headquarters, Solon, Ohio, United States
  • 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.