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CDMO

Contract Development and Manufacturing Organisation

As a trusted CDMO partner, we combine R&D, formulation, and scalable manufacturing to meet your unique needs. With a focus on quality and speed, we provide seamless support throughout the lifecycle of your product.

Drug Substance CDMO Services

At CRAMSN Research Park, we offer comprehensive process development services to identify and optimize the most efficient and scalable processes for New Chemical Entities (NCEs), Advanced Intermediates, and Key Starting Materials (KSMs). Our approach is centered around customer requirements, ensuring that every stage of development aligns with their goals for reproducibility, consistent quality , robustness, production friendly cost-effectiveness, and regulatory compliance.

We adopt a phase-appropriate process development strategy, allowing for seamless progression from early-stage research to commercial manufacturing. Our interdisciplinary team focuses on designing sustainable synthetic routes that enhance productivity and minimize risks. Key considerations in our approach include:

  • Selection of RAW material and reagents - the synthetic routes are designed based on the easy availability of the raw materials commercially during the design phase. The reagents and raw materials contributing to generation of GTIs and Nitrosamines are avoided during the exploration of synthetic routes
  • Green and sustainable chemistry - CRAMSN do involve in the design of chemical processes that minimise or eliminate use or generation of substance hazardous to humans , animals, plants and environment during the process optimization phase the green chemistry principles during the process development include Atom economy, Process Mass Index(PMI), E Factor etc
  • Meticulous optimization to understand the CPP’s using DoE approach
  • Development of Robust analytical methods for seamless identification of impurities
  • Tailor-made or Telescope approach to improve efficiency and lower the production costs
  • Accelerated scale-up timelines to ensure a faster transition from development to manufacturing

By integrating advanced process optimization techniques(DoE Approach) with cutting-edge analytical and engineering solutions, CRAMSN Research Park delivers robust, scalable, economical and regulatory-compliant solutions that help accelerate the journey from discovery to commercialization.

Drug Product

CRAMSN’s drug product development services offer unparalleled expertise and cutting-edge facilities designed to meet the most demanding industry standards. Our advanced development center is equipped with specialized analytical and formulation laboratories, enabling precise and efficient drug formulation. Complemented by GMP-accredited manufacturing suites, we ensure that every product adheres to the highest quality and regulatory standards. . At CRAMSN, we are committed to providing end-to-end solutions that accelerate the success of your drug products, with a focus on quality, innovation, and efficiency at every stage.