At Aurigene, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of small molecules development activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including New Chemical Entity (NCE), advanced intermediates and Key Starting Materials (KSM).
We provide small molecules development services from our R and D center in Hyderabad. This facility handles process development and non-GMP supplies at a 0.5-kilogram to 2-kilogram scale and enables the tech transfer to GMP facilities for clinical supplies. This facility is equipped with 15 chemistry labs and an analytical center of excellence that is fully equipped for chromatography, characterization, spectroscopy and thermal analysis.
Our R and D center houses a dedicated high potent lab. The peptide labs are housed with manual and automatic synthesizers that can handle solid, liquid, and hybrid synthesis. The high potent lab can handle products with OEL <0.1 µg/m³. In addition, we operate 3 non-GMP kilo labs including a steroid line.
We also have labs that carry process safety and powder safety studies. Our crystallization and risk assessment lab carries out a comprehensive solid-form screening, crystallization, and development of API to meet the desired specifications including solvent screening, polymorph screening, solubility studies, crystallization studies, PAT studies, scale-up studies and particle size distribution.
Clinical and commercial supplies are enabled through our eight US FDA-inspected GMP facilities across India, UK and Mexico. The sites can handle various technology platforms and have a variety of unit operations to suit our customer’s unique development needs.
Other Services
- Analytical Development and Validation Development Services
- Crystallization and Polymorphism Development Services
- Small Molecule Drug Discovery Services
- Non-GMP Pilot Development Facility
- Process and Powder Safety Assessment and Studies
Analytical Development and Validation Development Services
Crystallization and Polymorphism Development Services
Small Molecule Drug Discovery Services
Non-GMP Pilot Development Facility
Process and Powder Safety Assessment and Studies
Process Development and Validation Development Services
Small Molecules Manufacturing Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Polymorph Screening
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
NOVEMBER 16, 2023
The importance of business continuity planning in CRDMO industry
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...
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Evolution in Pharma Industry and Demand for Integrated CDMO
The pharma industry is evolving and a demand for integrated CDMOs, which can help accelerating innovations, is part of the evolution....
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
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August 28, 2020
A cascade reaction for the new and direct synthesis of indolofuroquinoxalines
The 7H-indolo[30 ,20 :4,5]furo[2,3-b]quinoxaline derivatives are synthesized directly from methyl 2-(2- chloro-1H-indol-3-yl)-2-oxoacetate or its N-alkyl derivatives under neutral or mildly acidic conditions. This new one-pot methodology was found to be general and greener as it avoids the use of environmentally harmful POCl3 and strong alkali required for the pr...
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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
What are the key challenges in process development for small molecules?
Challenges include reaction scalability, impurity control, and cost-effective synthesis. Aurigene applies optimized synthetic routes and process design to improve efficiency and scalability.
How are solid-state properties evaluated during development?
Techniques such as XRD and DSC are used to assess crystallinity and polymorphism. Aurigene integrates solid-state characterization to ensure consistent API performance.
How is polymorphism managed in small molecule development?
Polymorph screening identifies stable crystal forms to ensure consistent solubility and bioavailability. Uncontrolled transitions can affect drug performance.
How are dissolution profiles optimized during small molecule development?
Dissolution is optimized through particle size control, salt formation, and formulation strategies. Poor dissolution can limit bioavailability despite strong potency.
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