Syngene Annual Report 2025

ANNUAL REPORT 2025

Corporate overview

Contract Development and Manufacturing Services (CDMO)

Divisional reviews

Essential functions

Performance & Specialty Materials (PSM)

Case Study 1

Pharmaceutical Development

Biopharmaceutical Development

Computational and Data Sciences, Discovery Services

Case Study 6

Integrated Drug Discovery (IDD)

Case Study 8

Discovery Chemistry, Discovery Biology and Synvent

Case Study 9

Case studies

Leadership

Statutory reports

Financial statements

×

Home | Business Review | Our Services

Business Review

Our Services

End-to-end cross-functional, cross-modality delivery of key elements across the discovery and development continuum…

	Target Identification and Validation	Hit Identification	Hit to Lead	Lead Optimization	IND Enabling	IND / Ph1 DE
Discovery Biology (Small and Large Molecules)	Target ID Pathway analysis Omics (Gene and protein) Knock-in / knock -out Literature survey Market analysis	Tool Discovery Antibody Library screening Hybridoma Transgenic mouse NCEs	In vitro/Insilco assays: Seq optimization Cellular Mechanistic Relevant Off-Target(s)	In vivo assays/ studies: PK (R/NR) PD, PK/PD Efficacy testing	Later Translational: PK/PD/Efficacy Refinement of patient selection hypothesis Biomarkers	Ph1-HV or Patient (as appropriate): Exposure PD
			In vitro ADME assays: Protein Binding Metabolism CYP Inhibition/ Induction
	Bioinformatics: Sequence Analysis Screening Target Engagement CDR Grafting	In vitro assays: Biochemical Orthogonal Cellular assay - HTS/HCS Formats	Research Operating Plan: Assay Priority Key Studies & critical path	Hypothesis: Patient Selection	Human Dose Projection h-PK Projection PK/PD/Efficacy data Safety/Tox data	Drug Substance (DS, aka API) Route Scouting Scale Up Manufacture/ Stability
Chemistry Development Formulation Clinical Development	HTS/DEL/Fragments/Virtual Screening Library Design/Synthesis/Maintenance Hit Validation, Re-synthesis Series Qualification, Prioritization	Optimization: Biochemistry/ Cell Potency Selectivity Phys/Chem Properties In Vitro/Vivo Tool compounds	Optimization: Target Optimal h-Profile Candidate Selection Backup Strategy Cell line development: Cell line development Process and analytical development	Drug Substance (DS, aka API) Route Scouting Scale Up Manufacture/ Stability Process Lock-down Process Characterization Method Qualification MCB and GLP manufacturing	Drug Product (DP) Pre-Formulation Studies Ph1 Suitable Formulation Prototype/ Stability Manufacture/ Stability IND, BA/BE, DDI and Phase 1 clinical trials GCP Bioanalysis
Safety Assessment			In vitro Safety: hERG Ion Channels	Tox-Suitable Formulation (maximize exposure)	DRF Tox (R/NR) Bioanalysis GLP Tox (R/NR) GLP Bioanalysis	MTD or RP2D (as appropriate)

Informatics

Integrative Data Analysis, Predictive Modeling, Hypothesis Generation

Through commercialization, both standalone and integrated offerings

	Developability Assessment	Development Phase	Clinical Phase Phase I Phase II Phase III	Registration/ Process Validation	Commercial Batches
Safety Assessment	Early PK, MTD/ DRF studies, Exploratory Tox	IND enabling GLP Tox studies: Ames, Chromosomal aberration, Micronucleus tests, Pivotal repeat dose (Rodent and Non-rodent) Safety Pharmacology: CNS, Respiratory, CV Telemetry, hERG	NDA enabling studies: Subchronic and Repro-tox studies Local Chronic study Chronic and Carcinogenicity study
Chemical Dev and Manuf.	Route scouting Process safety evaluation Scalability	Fit to purpose Process dev Material supply Impurity identification Enable and scale Tox material delivery	Process dev, robustness and safety study Unit operation studies Impurity synthesis & characterization DS clinical batch supply	Process DOE, QBD and scale up studies Process Risk assessment FMEA analysis Registration and process validation batches manuf.	Commercial batches manuf. and packaging
Formulation Dev and Manuf.	Pre-formulation Salt polymorph screening Excipient compatibility	Solid Oral & Injectable dosage forms Enabling formulation technologies	Clinical Supplies for all phases FIH formulation for Phase 1/2A Final dosage form for Phase 2B/3 and onwards		Commercial batches manuf. and packaging
Analytical Services	Methods for Preformulation and Bio-analytical	Methods for Intermediate, Final DS, DP Forced degradation studies Solid state characterization	Phase appropriate method validation for DS & DP (microbial methods) Specifications for DS & DP In process and Finished product analysis Final batch release with COA Reference standard , Impurities, Isolation and characterization	Robustness of Analytical methods and full validation as per ICH	Analysis of commercial batches
Stability Services	Selection of suitablecontainer closure system & packaging	Development stability studies	ICH stability for all phases Shelf-life Estimation Re-test extension	Stability study of registration/ process validation batch	Stability study of commercial batches
Clinical Development			Human Pharmacology Unit (Phase I/BE studies) Clinical Trial Services – full solution provider for conducting trials in India Central Lab Services including regulated bioanalytical lab Clinical data management, biostatistics and medical writing

Regulatory Support

Strategic Priorities

Operating Environment

Download Center

Board Report

Standalone Financial Statements

Corporate Governance Report

Consolidated Financial Statements

Business Responsibility and Sustainability Report

Glossary

Management Discussion and Analysis

AGM Notice

Annual Report 2025