Alentris Research Pvt Ltd is a leading company in the custom synthesis field, with extensive experience in managing impurities during the scale up at Kilogram scale during synthesis process. The company’s team has specialized knowledge in organic synthesis, analytical chemistry, and process development. The company’s quality control team uses advanced analytical techniques, such as NMR spectroscopy and mass spectrometry, to ensure that the final product meets the client’s specifications.
Our R & D Team capabilities: Various complex heterocycles, Synthetic Chemistry, Process Chemistry, Library Design Synthesis, high purity standards, metabolites, Genotoxic substance, prodrugs, targeted compound libraries, to known and novel compounds.
Route selection / process development / Yield optimization / Method optimization
Pre-commercial work: exclusive synthesis / custom work for innovators on NCE candidates
Technology transfer from gm to Kg level and up to commercial level.
Pilot plant facilities: 50 L, 100 L, 200 L cylindrical glass assembly
Custom Synthesis and Contract Research and Manufacturing Services (CRAMS) are two closely related segments of the pharmaceutical and chemical industries. These services play a vital role in drug discovery, development, and manufacturing. Let’s explore these concepts further:
Custom synthesis and CRAMS businesses are integral to the pharmaceutical and chemical industries. They offer a wide range of services, from custom chemical synthesis to comprehensive drug development and manufacturing support. The industry continues to evolve in response to changing market demands and regulatory requirements.
Both custom synthesis and CRAMS are popular outsourcing options for pharmaceutical companies. Outsourcing can reduce costs, expedite development timelines, and access specialized expertise and facilities.
In the pharmaceutical industry, adherence to strict regulatory guidelines (such as Good Manufacturing Practices, GMP) is crucial. CRAMS companies need to ensure that their manufacturing processes meet these regulatory standards to deliver safe and effective products.
Due to the sensitive nature of drug development, clients often require strict confidentiality agreements when outsourcing custom synthesis or CRAMS services to protect their intellectual property (IP) rights.
The custom synthesis and CRAMS market is global, with companies operating in various regions. India and China, for example, have become prominent players in this industry due to cost advantages and technical capabilities.
The industry is highly competitive, with many contract service providers vying for clients. Companies differentiate themselves through expertise, quality, regulatory compliance, and cost-effectiveness.
Recent trends in the industry include an increased focus on green chemistry and sustainability, automation and digitalization of manufacturing processes, and the development of specialized capabilities in niche areas like biologics and gene therapy.