Aurigene has a legacy of developing 500+ molecules, several of which are in the commercial phase in highly regulated markets such as the USA, Europe, Japan, etc. We support our customers at various stages of a late-phase product from regulatory filing to launch and at the patent expiry stage with cost optimization options. Our vast manufacturing footprint allows us the flexibility to choose from a variety of unit operations suitable for product manufacturing. Our expertise in regulatory filings and documents will help our customers create comprehensive documentation for NDA and other global regulatory filings.
We offer a wide range of manufacturing services from a few kilos to multi tons of cGMP manufacturing of Key Starting Material (KSM) / Registered Starting Materials (RSM), advanced intermediates, and APIs. Our facilities can handle a diverse set of chemical reactions at various scales. Our facilities are inspected by global regulatory authorities like the US FDA, UK MHRA, TGA Australia, PMDA Japan, and other regulatory agencies. Our facilities can handle the manufacturing of niche technologies like peptides, High Potent Active Pharmaceutical Ingredients (HPAPIs), steroids, Methoxy Polyethylene Glycols (m-PEGs), and prostaglandins. Our state-of-the-art facilities are located across the globe in India, the UK, and Mexico.
All manufacturing facilities are equipped with particle size regulating equipment including multi-mill, air jet mill or micronizer, sifter, and blenders. Dedicated unit for the micronization of steroid products. Steroid manufacturing facility is also equipped with micronizer.
Development/PoC
Development/PoC/Non GMP
Purification: GPC technique, size-exclusion chromatography, SAX purification, Ion-exchange chromatography
Sustainability is one of our core values and we continue to build on our goals aligned with global standards. Our work in the field of sustainability was recognized by:
Our development center is a US FDA audited facility, and our manufacturing plants are regularly audited by the US FDA, EDQM, KFDA (Korea), MHRA (UK), PMDA, SFDA, CDSCO, DMA, TGA, WHO GMP, and COFEPRIS.
US FDA Inspected Labs
Integrated Development and Manufacturing
25 to 50 gms per batch
Dedicated Analytical Lab
JUNE 28, 2022
Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...
Read MoreBuilding successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...
Read MoreWe are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
Read More2023
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 More2021
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 More2021
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. ...
Read More2021
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...
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