At Aurigene, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of small molecules development activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including New Chemical Entity (NCE), advanced intermediates and Key Starting Materials (KSM).
We provide small molecules development services from our R and D center in Hyderabad. This facility handles process development and non-GMP supplies at a 0.5-kilogram to 2-kilogram scale and enables the tech transfer to GMP facilities for clinical supplies. This facility is equipped with 15 chemistry labs and an analytical center of excellence that is fully equipped for chromatography, characterization, spectroscopy and thermal analysis.
Our R and D center houses a dedicated high potent lab. The peptide labs are housed with manual and automatic synthesizers that can handle solid, liquid, and hybrid synthesis. The high potent lab can handle products with OEL <0.1 µg/m³. In addition, we operate 3 non-GMP kilo labs including a steroid line.
We also have labs that carry process safety and powder safety studies. Our crystallization and risk assessment lab carries out a comprehensive solid-form screening, crystallization, and development of API to meet the desired specifications including solvent screening, polymorph screening, solubility studies, crystallization studies, PAT studies, scale-up studies and particle size distribution.
Clinical and commercial supplies are enabled through our eight US FDA-inspected GMP facilities across India, UK and Mexico. The sites can handle various technology platforms and have a variety of unit operations to suit our customer’s unique development needs.
APRIL 24, 2023
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...Read More
The pharma industry is evolving and a demand for integrated CDMOs, which can help accelerating innovations, is part of the evolution....Read More
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...Read More
The 7H-indolo[30 ,20 :4,5]furo[2,3-b]quinoxaline derivatives are synthesized directly from methyl 2-(2- chloro-1H-indol-3-yl)-2-oxoacetate or its N-alkyl derivatives under neutral or mildly acidic conditions. This new one-pot methodology was found to be general and greener as it avoids the use of environmentally harmful POCl3 and strong alkali required for the pr...Read More
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 More
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis . It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization . IUPAC name of Cholecalciferol is (3β, 5Z, 7E)- 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formul...Read More
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 More
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