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
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Toxicology Studies
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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.
Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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Frequently asked questions
What is a toxicology study?
Toxicology studies help drug discovery scientists understand the adverse effects of New Chemical Entities (NCE) when administered to treat a disease. The studies are done on in-vitro assays and in in-vivo animal models to know the toxicity profile.
What are GLP toxicology studies?
Good Laboratory Practise (GLP) toxicology studies are conducted under certified regulatory conditions. The studies are carried out based on procedures laid down by OEDC principles.
What is the purpose of toxicology studies/tests?
The purpose of toxicology studies/tests is to know the adverse/harmful effects of New Chemical Entities (NCEs) on the body of the organism on administration. These studies/tests help drug discovery scientists to design drugs.
Why do toxicology tests take so long?
Toxicology tests require a lot of time for chronic toxicity tests (6 to 12 months), other studies such as sub-acute (14 to 28 days), sub-chronic (90 days) require less time when compared to chronic toxicity tests.
What are the laboratory animal species used in in-vivo toxicity testing?
Mice, rats, guinea pigs, hamsters, rabbits, dogs, monkeys, and minipigs are commonly used in in-vivo toxicity testing.
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