We provide clinical supplies and commercial supplies of APIs through our 8 US FDA-inspected cGMP manufacturing sites across India, UK and Mexico. We operate thousands of kilo liters of reactor volumes with thousand-plus reactors in intermediate blocks and clean rooms out of which hundreds of reactors can cater to special technologies like High Potent APIs (HPAPIs), Peptides, Steroids and Prostaglandins. All our plants are operated by cGMP (ICH Q7a) and regularly inspected/audited by international authorities and customers.
We offer manufacturing services in a wide range of scales and are expanding our capabilities while maintaining high safety standards. With Electronic Batch Production Record (EBPR) and Electronic Lab Notebook (ELN), we are expanding our digitalization functionality.
Our facilities are operated with sustainability as one of the focus areas with principles around environmental and social governance intact. Operations of our sites are linked with processes around: Green Chemistry, waste minimization, waste management, water neutrality, emission control, reducing carbon footprint and usage of renewable power, people practice, community development activities, and a strong focus on ethics compliance and transparency.
Why Aurigene Small Molecules Manufacturing Services?
20+ years of legacy, worked on 500+ molecules, 15+ commercialized
Plants across continents (India, UK, Mexico)
Global regulatory inspections (USFDA, PMDA, EDQM, MHRA etc.)
Wide range of technologies & niche reactions (Peptide, Steroid, High potent)
High quality and flexible scale production
Extensive process safety and hazard analysis
Integrated QC testing and release
Other Services
- Small Molecule Drug Discovery Services
- Intermediates and API Contract Manufacturing Services
- Pharma API Manufacturing Sites & Capabilities
- Pharma API Technology Transfer Services
- Small Molecules Development Services
Small Molecule Drug Discovery Services
Intermediates and API Contract Manufacturing Services
Pharma API Manufacturing Sites & Capabilities
Pharma API Technology Transfer Services
Small Molecules Development Services
Special Unit Operations Services
Specialized Chemistry Development and Manufacturing Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
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
Oligonucleotide as a novel class of therapeutic modality
Oligonucleotides as a therapeutic class is a revolutionary approach to discover new and important therapeutic agents for treating human diseases. RNA-based intervention at times works in cases where other modalities do not work. For example, it may help in treating inborn errors in metabolism, genetic disorders and rareOligonucleotide therapeutics is the use of c...
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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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cGMP Development and Manufacturing Services
Aurigene Pharmaceutical Services has a legacy of +20 years in developing and manufacturing compounds under cGMP. Our manufacturing plants are spread across 3 continents with facilities in India, UK, and Mexico. ...
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Solid dispersion development to enhance solubility and oral bioavailability for rodent toxicology studies
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in rats. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies. Challenges: Low oral bioavailability Practically insoluble in bio relev...
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
2016
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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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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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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Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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