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 Pharmaceutical 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
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Resources
JULY 02, 2021
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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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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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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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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