Chemxtel labs regulatory team is comprised of experts experienced in all regulatory issues. We focus on the clients needs and requirements, to provide services of high quality that meet their expectations.

Addressing the agency quarries/questions with experimental evidences like Spike purge studies, Purge factor report by using ICHM7 guidelines option 4, process related justifications by the evidences of the literature supports.

We provide custom API development services from our R and D center in Hyderabad. This facility handles process development and enables the technology transfer to GMP facilities for clinical supplies. We also have risk assessment lab carries out a comprehensive solid-form screening and crystallization to development of API to meet the desired specifications including solvent screening, polymorph screening, solubility studies, crystallization studies, scale-up studies .

If you can draw a chemical structure, we will make it for you in the flask. We do Custom synthesis from milligrams to kilograms. If you have a laboratory process or similar literature data we will take it further. Or else we can provide complete solution from retro synthesis of your desired structure to identify the route and define chemistry for the synthesis. We serve on FTE as well as gross cost model as per your convenience. In any of the cases, confidentiality of your data will be our top priority along with strict adherence to timelines.

Chemxtel labs goal is to build long term relationships with its customers by providing consistently high quality products, dependable service and on-time delivery at highly competitive prices.

Impurity synthesis and identification of unknown impurities, Process related & OOS impurities is the major activity at Chemxtel labs. Our team has developed intense knowledge and understanding of the impurity synthesis process. Even though impurities are the major products we sale; we also undertake custom synthesis orders for synthesis impurities in gram levels. It is very important to understand the reaction parameters/mechanisms responsible for generation of specific impurity in a chemical reaction. Our team is well-versed with the mechanistic aspects of organic synthesis.