CDMO

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CDMO Capabilities at Emnar

At Emnar, we provide comprehensive CDMO solutions covering the entire pharmaceutical development lifecycle — from discovery chemistry to commercial supply. Our multidisciplinary teams and world-class infrastructure support a wide range of services across various therapeutic segments, with a strong focus on APIs and intermediates.

Research & Development

  • Non-infringing route development (IP-friendly synthesis)
  • Polymorph and salt screening
  • Analytical method development and validation
  • Process safety evaluation
  • Impurity profiling and forced degradation studies
  • Green chemistry and process efficiency improvement

Manufacturing Facilities

  • 4 manufacturing units across Telangana with backward integration
  • API and intermediate manufacturing in ISO 8/9 cleanrooms
  • Dedicated reactors (glass-lined, SS, Hastelloy) Cryogenic reactors, vacuum tray dryers (VTD), RCVDs, ANFDs, FBDs
  • Continuous flow and semi-continuous capabilities
  • Solvent recovery and zero liquid discharge systems

Custom Synthesis & Chemical Development

  • Custom synthesis of building blocks, intermediates, and NCEs
  • Handling of sensitive and hazardous chemistries (e.g., nitration, cyanation)
  • High-pressure and low-temperature reaction capabilities
  • Asymmetric synthesis, chiral resolution, and stereoselective reactions
  • Hydrogenation, bromination, halogenation, and more

Quality & Regulatory Compliance

  • Facilities approved by USFDA, EDQM, KFDA, WHO-GMP
  • ICH Q7-compliant documentation and processes
  • EHS-compliant waste management and safety protocols
  • Track record of successful audits by global clients and agencies

Process Scale-Up & Optimization

  • Scale-up from gram to multi-metric ton level
  • DoE (Design of Experiments) and QbD-based optimization
  • Tech transfer from lab → pilot plant → production
  • cGMP and non-GMP scale-up in dedicated suites
  • Handling of OEB 4 and OEB 5 category compounds (oncology, HPAPIs)

Packaging, Warehousing & Supply Chain

  • cGMP-compliant warehousing with climate control
  • Serialization-ready packaging
  • Real-time tracking and cold chain management (as required)
  • Integrated logistics and export documentation support

Analytical Services

  • Analytical method development & validation (ICH guidelines)
  • Elemental impurity profiling (ICP-MS)
  • Residual solvents, particle size analysis, and thermal studies
  • Stability studies (ICH zones)
  • Support for regulatory filings (DMF, ANDA, NDA, CEP)

Strategic Advantages

  • Speed-to-market: Rapid development with parallel scale-up and documentation
  • Confidentiality: Strict IP protection and client confidentiality
  • Cost-efficiency: In-house KSM manufacturing to control costs and supply chain
  • Collaboration: Long-term partnerships with flexibility in engagement models (FTE, fee-for-service, milestone-based)

Sustainability Air, Water & Waste Management

  • We actively work to limit emissions into the air and water by implementing real-time monitoring systems across our facilities.
  • All environmental metrics—including VOCs, greenhouse gases, and wastewater—are tracked and managed in accordance with international standards.