CRAMS & CDO

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CRAMS & CDO

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 centre and manufacturing site have been recognized by regulatory agencies in India and US. With a 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