Contract Development and Manufacturing Organization (CDMO)
We provide end-to-end services to bring a drug to the marketplace quickly and safely. We offer Pharmaceutical Development and Manufacturing solutions through the drug life cycle.
At LAXAI, we have created the infrastructure to provide services for an effective management of drug’s life cycle. We provide services from Discovery to Development and Commercial Manufacturing of NCEs. Our capability as an integrated service provider and experience with various technologies enables us to serve Innovator companies worldwide. At LAXAI, our focus is on serving as a 'Customer Centric' organization. We accomplish this by keeping the "Pulse of the Customer" at the heart of our mission. We have a robust feedback mechanism which enables us to continuously improve our internal processes, communications and program management.
From Concept to commercialization
We help to increase the efficiency of production processes and reduce the risks associated with product development and/or commercialization. In this endeavor, our approach is to improve and back integrate the stages which are limited for scalability in the initial discovery thereby making the entire drug life cycle process more cost efficient with higher yields.
Meeting Your Small Molecule Needs
LAXAI recognizes that synthetic chemicals still represent 80 to 85% of the drugs on the market as well as those in late-phase of development. We strive to adopt a broad, balanced and innovative portfolio of chemical technologies to suit the needs of our clients. Using various latest chemical processes - including continuous flow technologies and biocatalysis- we offer our customers exclusive synthesis of synthetically challenging high value KSMs, RSMs and NCEs under cGMP for use in pharmaceutical products.
Backward-Integrated Industrial Manufacturing
We can manufacture quantity from kilo to tonne scale. Our manufacturing strength stems from our comprehensive integrated network of resources for backward integration of starting materials/reagents, non-GMP intermediates at scale and securing the supply chain in terms of quality and costs. Our global footprint provides a highly valued risk mitigation and IP clean (in case of new synthetic route) asset.
LAXAI offers entire services for Intermediates, API and Formulation Development including Lab assessment, Process optimization, Scale-up, Synthesis and commercial Manufacturing. LAXAI’s state-of-the-art facilities including Analytical facility helps us to handle complex API’s and Intermediates and highly potent materials at both developmental and commercial scale. Its competent and experienced team with global experience capable to deliver the projects at agreed timelines with unparalleled quality and cost. Our proactive project management system offers seamless communication for project updates to clients. LAXAI has globally compliant cGMP, USFDA, MHRA, K-FDA and COFEPRIS approved facilities.
- Improved product quality - every development project request is carefully analysed and various alternative options are explored for arriving at the best solution.
- Create a robust, comprehensive control strategy using the principles of the Design of Experiments (DoE) and Quality by Design (QbD). This enables the chemistry developed to be readily scaled as the molecule advances from early clinical phase to commercial production.
- Speed to market by focusing resources on core competencies and optimizing, ROI.
- Access to our advanced technologies and optimized processes to achieve CMC development milestones.
- Benefit from LAXAI’s experience with world-wide regulatory authorities.
- We have a team of professionals with international experience dedicated to deliver successful outcome for our collaborators.