CRAMS & CDMO

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CRAMS & CDMO

CRAMS & CDMO

We are a Contract Development and Manufacturing Organization (CDMO), offering end-to-end services to speedup launch of a new drug to the market. We offer process development and technology transfer and manufacturing through collaborative partnership. We co-develop the end product and support the entire life cycle of a drug molecule and advanced intermediate.

Our R & D center and manufacturing site have been recognized by regulatory agencies in India and US. With strength of 80 scientists, we are focused to develop processes and achieve optimum cost for manufacturing under strict regulatory compliance.

Services Offered:

  • Process / route selection
  • Process development for pre-clinical and clinical supplies
  • Analytical method development and validation
  • Critical process parameters assessment
  • Process validation and stability studies
  • Technology transfer and manufacturing support
  • Vendor identification and development for key raw materials

Site Capabilities:

  • Pilot scale reactors ranging 500 – 2000L (stainless steel / glass-lined)
  • Hydrogenation facility
  • Kilo lab / Scale up facility 50 – 100L Glass assemblies
  • Drying, milling, micronisation and packaging facility
  • Well-equipped QC laboratories

Salient Features:

  • State of art lab services and production pilot plants
  • Manufacture of low volume “niche” APIs
  • US FDA and WHO Approved manufacturing facility
  • Onsite Quality Assurance and Regulatory Affairs support