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
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 MoreChallenges: Several repeated in house validation studies were performed to optimize the suitable perfusate (liquid medium intended to pass through the heart), perfusate volume and perfusion rate to ensure complete perfusion of animal subjects (parameters weren’t adjustable) Challenges were encountered in adjusting the perfusion volume and rate vis-à-vis ensuri...
Read More2008
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...
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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