Commercial Manufacturing of APIs, Intermediates, KSMs, RSMs
LAXAI is a leading provider of cutting-edge technologies and scientific expertise for the commercial manufacturing of APIs (Active Pharmaceutical Ingredients), intermediates, KSMs (Key Starting Material), and RSMs (Reactive Starting Material) in compliance with current Good Manufacturing Practices (cGMP) and other quality standards.
We pride ourselves on our commitment to operational excellence and the reliable manufacturing of commercial supplies in a timely and cost-effective manner. To achieve this, our manufacturing processes are fully integrated with quality control, quality assurance, supply chain management, regulatory, and project management.
The commercial manufacturing of APIs, intermediates, KSMs, and RSMs requires specialized expertise, infrastructure, and equipment to ensure the safety, efficacy, and quality of the final product. Our facilities are equipped with advanced technologies, automated systems, and quality control processes to monitor and optimize the manufacturing process.
Our commercial manufacturing process involves the synthesis, purification, isolation, and formulation of these chemical compounds to ensure the consistency in quality, purity, and potency of the product.
The chemical synthesis of the target compound typically starts from KSMs or RSMs.
The purification of the product uses various techniques such as crystallization, distillation, and chromatography to remove impurities and obtain a high-purity product.
The isolation of the product from the reaction mixture and the removal of any residual solvents or impurities is then carried out.
Finally, the formulation of the product into the final dosage form, which may involve additional processing steps such as granulation, compression, and coating, is performed.
We are committed to delivering high-quality products that meet the needs of our clients and their customers. With our expertise and state-of-the-art facilities, we are dedicated to providing reliable and cost-effective commercial manufacturing solutions for our clients.
Infrastructure and Instrumentation:
- Laboratory reactors: 2L to 10L
- Kilo lab suites: 64L to 250L at the Research & Technology facility
- Process engineering production block mimics larger scale equipment
- Reactor sizes of 64L to 3KL also available
- 250L and 1KL reactors to handle cryogenic conditions
- Hydrogenation capacity from 1L up to 1KL
- Cleanrooms and high potency suites