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.
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
JULY 02, 2021
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...
Read MoreThe pharma industry is evolving and a demand for integrated CDMOs, which can help accelerating innovations, is part of the evolution....
Read MoreAurigene 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. ...
Read MoreBackground: 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...
Read More2016
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...
Read More2005
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 ...
Read More2005
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 ...
Read More2005
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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