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Preclinical and Clinical API Supply
 
Taj offers both the expertise and equipment to help synthesize API at gram scale, quickly, and under current Good Manufacturing Practice (cGMP) guidelines. At this early stage of development, the goal is to establish the infrastructure and chemistry processes needed to advance an API forward in development.

Our development chemists provide technical assistance early in any drug development program. They can assist with a range of challenges, from creating a process for a new compound to simply refining an existing lab-scale procedure. This includes the selection of materials and equipment that are consistent with cGMP guidelines. Years of experience with organic synthesis ensure that the processes we create are suitable for scale-up and will pass the scrutiny of the FDA, MHRA, and other international regulators.

Preclinical
Taj can provide all preclinical supplies including drug substances for toxicology studies and radiolabeled drugs (14-C or tritium) for animal or human metabolism studies. Developing synthetic procedures for both non-labeled and labeled drug substances provides the opportunity to learn about the chemistry from different views, and gain expertise in the synthetic routes. This synergy often results in significant time and cost savings, as well as a superior manufacturing process.

Clinical

Taj also meets bulk production needs at every phase of clinical trials. Through a quality by design approach we provide bulk actives and intermediates that are manufactured under strict cGMP guidelines, scrutinized by Quality Control, and approved by Quality Assurance. Additionally, we can provide cGMP radiolabeled drug substances for studies involving human subjects.


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Active Pharmaceutical Ingredients manufacturer, exporter, drug ingredients, pharmaceuticals, India
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