We have one of the largest capacities in the world to manufacture highly potent compounds with Occupational Exposure Limit (OEL) in the range of 0.1-1 μg/m3 (OEB 5). Our facilities are audited by US FDA and regulatory bodies.
We offer manufacturing of high potent compounds supported by special unit operations like micronization and spray drying. Our facility is designed to give output as low as 100 gm to multi-tons.
Our approach for high potent handling
We provide high potent API manufacturing services from 3 sites based out of India. All sites are inspected by US FDA and other reputed regulatory bodies. Some of the key features of sites are as listed below:
We take utmost care in handling highly potent materials at every stage of the manufacturing journey.
The manufacturing process starts with reaction, sampling, workup, and isolation, followed by filtration and drying operations. The facility also has special unit operations across all the modules ranging from material removal into the canister, layer separation, drying, rotation evaporator, spray drying, and micronization. All modules have ANFD and micronizers in SS packing isolators.
All the analysis steps, such as in-process, intermediate, and complete, are performed in a dedicated QC lab designed to handle high potent molecules. The QC lab is equipped with a weighing and sample preparation isolator. The samples are analyzed using various equipment such as HPLC or GC. The QC lab relates to Empower 3 servers and all the data related to in-process, intermediate, and complete analysis steps are transferred to SAP through LIMS software.
Our manufacturing processes follow not only the highest quality but also sustainability standards to protect the environment and our workforce. The effluents are treated and processed in detoxifying areas, as per regulatory standards.
One of the largest capacities in Asia- 3 US FDA inspected cytotoxic GMP facilities
Variety of unit operations in containment
Highest standards of safety
Experience in manufacturing 50+ high potent compounds
Dedicated high potent R&D facility allowing for faster development and technology transfer
MAY 19, 2023
Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they loss. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.  ...
Read More 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 contract development and manufacturing organizations (CDMOs) for collaborations as they seek more adaptable capacity and c...
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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 ...
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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. ...
Read More2005
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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