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Custom Synthesis |
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For clients requiring quick development support for initial clinical studies, preparing for launch of new molecules, and/or develop a competitive source of supply, Shasun Research Center has two models of operations to address the needs of clients. The work can be on purely purchase order basis or it could be a developmental work fees followed by a purchase order for required quantities. Our scientific team engages the best talent in the industry for the quick development of environmentally friendly, economically viable, and patent non-infringing processes.
Quotes are offered within a week of receipt of molecule disclosure along with proposed routes for synthesis. Timelines are planned according to the needs of the customer, and because of the vast resources available at times multiple groups may be engaged to meet the aggressive timelines set by the client. Intermediate scale-up and demonstration runs can be done at our pilot plant and synthetic kilo labs. Validation support and filing of CMC's sections for IND's is also provided.
Activities includes:
- Development of processes & synthesis of known products as per client’s requirement
- Simpler routes with efficient recovery, cost reduction for contract manufacturing
- Synthesis of Chemical Entities as per customer request
- Synthesis of known impurities and reference standards
- Synthesis of Scaffold and Building blocks
- Method development for “custom made” building blocks
- Synthesis of Novel Chemical Entities as drug candidates
- Synthesis of small library of compounds with each member specifically designed
- Development of value added products
A Typical examples:
An anti-hypertensive molecule was presented to Shasun for development as a source of supply in late 2001. Current literature had shown process difficulties in the product meeting the required specifications for known impurity. Shasun scientists developed a novel process for the same and sampled the client. With having got success, this project was put on a fast track and commercial launch was planned. Local supplier for the raw material was not available and Shasun developed the same through transfer of its technology. Facilities modifications were completed and process having more than 7 stages was validated in record time. Today, Shasun is only manufacturer for the compound apart from the original innovator.
Some of the key highlights include:
- Quick turnaround of proposals
- Scaling up of multi-step processes and achievement of high purities (>99%)
- Effective RM sourcing & extensive analytical support
- Cost reduction through cycle time reduction
- Simpler routes with efficient recoveries
- Identification and synthesis of impurities/ reference standards for testing
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