We provide custom API 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 technology 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 and peptide 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 lab.
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.
Resources
SEPTEMBER 04, 2023
Why meet us at CPHI Barcelona?
Discover the Opportunities: Visit Aurigene Pharmaceutical Services at CPHI BarcelonaThe Contract Research, Development and Manufacturing Organization (CRDMO) industry is a dynamic and rapidly evolving sector emerging as it plays a vital role in providing a wide range of services enabling drug companies to bring their products to market efficiently and effectively...
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Immuno Oncology - Therapies and Challenges
With more than 200 distinct cancer types recognized and steady increase in cancer incidence rates, the fight with cancer takes a new shape with each emerging decade. First was surgery, followed by radiotherapy and chemotherapy. The fourth one was targeted cancer therapeutics, also known as precision therapies. Precision therapies were established with the discove...
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Anti-Infective Drug Discovery
Objective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series. Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2023
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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A Sensitive and a Simple RP-HPLC Method Development and Verification for the Quantitative Estimation of Cholecalciferolin Tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. 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...
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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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