At Aurigene, we specialize in providing a broad spectrum of pre-clinical toxicology studies with a proven track record, tailored to meet the diverse needs of our clients. Our services include single-dose and repeat-dose toxicity, reproductive toxicity, in vitro and in vivo genetic toxicity, core safety pharmacology battery and long-term toxicity studies. Our clients have successfully filed IND/NDA/ANDA/505(b)(2) applications with regulatory authorities including the US FDA, MHRA, EMA, and DCGI.
Over the last 20+ years, we have conducted more than 1,000 exploratory toxicology studies, empowering early discovery efforts and facilitating informed candidate selection. Established in 2002, Aurigene Toxicology Services has been recognized for its commitment to quality, achieving GLP certification by the Netherlands in 2003 and National GLP Compliance Monitoring Authority of India (NGCMA) since 2004. The Test Facility is also fully accredited by the AAALAC for standard lab animal care since 2021.
Our mission is to help driving innovation and enable the seamless progression of drug discovery and development with reliability, precision, and regulatory compliance.
The team is proficient with a wide range of administration routes including oral, intraperitoneal, intramuscular, subcutaneous, intradermal, inhalational, intravitreal injection, and intricate intravenous infusions. We ensure timely and accurate communication across time zones by optimizing workflows, processes, and communication technologies.
The following section outlines the various general, reproduction and genetic toxicity studies conducted by our team. These studies are essential for evaluating the safety and efficacy of new drugs and compounds, ensuring they meet regulatory standards and are safe for use.
Why Choose Aurigene Pharmaceutical Services?
Proven experience with submissions to the US FDA, MHRA and DCGI
Team of highly qualified and experienced scientists
Capacity to handle more than 1000 rodents simultaneously
State-of-the-art infrastructure
Support for both standalone and integrated services for IND filings
Comprehensive biology capabilities for Integrated Drug Discovery
GLP certified and AAALAC accredited toxicology laboratory
Other Services
- Carcinogenicity Studies and Services
- DMPK Studies
- General Toxicology Services
- Genetic Toxicology Studies and Services
- In vitro Biology and Assay Services
Carcinogenicity Studies and Services
DMPK Studies
General Toxicology Services
Genetic Toxicology Studies and Services
In vitro Biology and Assay Services
In vitro Genotoxicity Testing Services
In vivo Pharmacology Studies and Services
Reproductive Toxicity Studies
Microbiology Testing Services
Safety Pharmacology Studies and Services
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Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Learning Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence bypass central thymic tolerance. The success of immune checkpoint blockade...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Systematic formulation design - shorten development cost & time
Project Challenge: Existing formulation (lower strength - 50 mg) was manufactured using direct compression process. This formulation posed poor powder flow and content uniformity issues during scale-up. Development of new strength 150 mg without any process issues was a challenge. Solution design: Preliminary pre-formulation, stress study and PSD impact assessmen...
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August 28, 2020
An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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April 21, 2026
H2SO4-SiO2 catalyzed synthesis, in silico and in vitro evaluation of quinazoline-based fused tetracyclic derivatives as new inhibitors of PDE4B
The 6,6a-dihydro-5H-isoquinolino[2,3-a]quinazoline-5,7,12-trione (DIQT) derivatives (that belong to the quinazoline-based fused tetracyclic class of compounds) though known in the literature, their biological properties have not been explored previously. In the current study, we have explored the phosphodiesterase 4B (PDE4B, an important target for the identifica...
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January 31, 2025
Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
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January 31, 2025
Development of novel paullone-based PROTACs as anticancer agents
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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Frequently asked questions
How does the Ames test detect mutagenicity, and what are its limitations?
The Ames test uses bacterial strains to detect point mutations induced by a compound. While highly sensitive, it may not reflect mammalian metabolism or complex DNA damage mechanisms.
What challenges are associated with interpreting positive genotoxicity results?
Positive results may arise from indirect mechanisms such as cytotoxicity or oxidative stress rather than true DNA damage. Aurigene applies a weight-of-evidence approach combining assay data, dose-response trends, and mechanistic insights to support accurate interpretation.
How are in vivo micronucleus assays used to confirm genotoxic risk?
In vivo assays evaluate chromosomal damage in bone marrow or peripheral blood, providing physiological relevance. Variability in exposure and tissue distribution can impact sensitivity.
How is clastogenicity differentiated from aneugenicity in genotoxicity testing?
Clastogens cause structural chromosomal damage, while aneugens affect chromosome number; differentiation is achieved using centromere staining or specific biomarkers. Interpretation may still be complex in mixed responses.
How are follow-up studies designed after inconclusive or borderline genotoxicity results?
Follow-up studies include additional in vivo assays or mechanistic investigations to clarify the mode of action and confirm risk relevance. Aurigene leverages flexible study designs, regulatory-aligned strategies, and integrated genotoxicity expertise to efficiently resolve inconclusive findings and support clear decision-making.
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