Syngene International

Syngene InternationalAn Indian CRDMO with a broad range of services from drug discovery research to non-clinical and clinical development, and manufacturing.We provide contract services including pharmacology, DMPK, safety assessment, and toxicity testing in-house, supporting everything from lead compound discovery to non-clinical development for IND submission.

Features of Syngene International's non-clinical contract testing services

End-to-end support from early drug discovery to IND submission

At Syngene,Non-clinical development combining pharmacology, pharmacokinetics, and safety evaluationIt supports this. In the early stages of drug discovery, pharmacology, PK, and exploratory toxicology are conducted, which then progress to GLP toxicity studies, safety pharmacology, and genotoxicity in subsequent IND-enabling studies. A key feature is the ability to build a data package for clinical trials by evaluating not only the efficacy of candidate compounds, but also systemic exposure and safety in a step-by-step manner.

GLP-compliant toxicity studies and safety evaluation

Non-clinical toxicity studies compliant with GLPWe also offer repeat-dose toxicity studies using rodents and non-rodents, as well as genotoxicity evaluations such as the Ames test, in vivo micronucleus test, and chromosome aberration test. For safety pharmacology, we conduct evaluations of hERG, CNS, respiratory, and cardiovascular systems. The 2026 annual report also confirms the re-certification of our GLP facility by India's National GLP Compliance Monitoring Authority.

From DMPK to the preparation of data for regulatory applications

In DMPK,Multifaceted evaluation of drug absorption, distribution, metabolism, and excretionAdditionally, we can evaluate the exposure levels and bioavailability of candidate compounds. Furthermore, we offer SEND services with FDA submissions in mind. Not only can we convert data from in vivo studies conducted in-house, but we can also convert non-clinical toxicity study data generated by other CROs into the SEND format. With a track record of converting over 2 million data points into the SEND format since 2018, we support the preparation of non-clinical data for regulatory submissions.

An example of a disease model owned by Syngene International

At Syngene,In vivo pharmacology models across a wide range of disease areas including cancer, inflammation, metabolism, and neurologyIt supports evaluation using . By combining specialized teams such as Safety Assessment, pharmacology, and DMPK, we can comprehensively evaluate the efficacy and safety of candidate compounds. We also accommodate study designs tailored to research objectives.

Non-clinical study cases of Syngene International

Evaluate the safety and tumorigenicity of cellular therapeutic products

Syngene has published a case study on being contracted by Cytopeutics in Malaysia for the non-clinical safety evaluation of a cell therapy product.5 non-clinical studies including MTD test, toxicity test, and carcinogenicity testand also conducted a 26-week tumorigenicity evaluation using immunodeficient mice. We compiled data based on regulatory requirements and supported development for clinical trials and product registration.

Syngene International Company Profile