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.
Methoxy Polyethylene Glycol (m-PEGs)
Aurigene Pharmaceutical Services is a leader in the synthesis of activated MethoxyPolyethyleneGlycol(m-PEGs), With a comprehensive product range and customized services. ...
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Base mediated spirocyclization of quinazoline: one-step synthesis of spiro-isoindolinone dihydroquinazolinones
2020
A novel approach for the spiro-isoindolinone dihydroquinazolinones has been demonstrated from 2- aminobenzamide and 2-cyanomethyl benzoate in the presence of KHMDS as a base to get moderate yields. The reaction has been screened in various bases followed by solvents and a gram scale reaction has also been executed under the given conditions. Based on the controll...
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Ultrasound assisted rapid synthesis of mefenamic acid based indole derivatives under ligand free Cu-catalysis: Their pharmacological evaluation
2005
An improved and rapid synthesis of mefenamic acid based indole derivatives has been achieved via the ligand free Cu-catalyzed coupling-cyclization method under ultrasound irradiation. This simple, straightforward and inexpensive one-pot method involved the reaction of a terminal alkyne derived from mefenamic acid with 2- iodosulfanilides in the presence of CuI ...
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Formal synthesis of Cladospolide C & epi-Cladospolide C using R- (þ)-g-valerolactone as a chiral synthon
2005
The formal synthesis of Cladospolide-C and its analog is achieved by using enantiopure (R)-g evalerolactone 10. The significant points of this synthesis are the stereoselective dihydroxylation of a, bunsaturated ester 16 using Sharpless protocol, Wittig olefination of g evalerolactol 6 with triphenylphosphonium iodide salt 7, one pot selective oxidation ...
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Amberlite-15 promoted an unprecedented aza Michael rearrangement for one pot synthesis of dihydroquinazolinone compounds
2005
A new one pot multicomponent annulation strategy for the synthesis of various dihydroquinazolinone compounds has been developed using Amberlite-15 as a catalyst, giving good to moderate yields. In this reaction the substrate scope for amines and aldehydes was also investigated. The reaction has been checked on a large scale ...
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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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