Aurigene has two decades of experience in the development and manufacturing of steroids. From concept to launch, we can safely handle the development and scale-up of steroids in India and manufacture commercial quantities at our dedicated cGMP manufacturing facility in Mexico. Our development and manufacturing services for steroids are supported by the dedicated facility with high end infrastructure.
Summary of our Services
We have proven expertise in the development and manufacturing of human and veterinary steroids. We are one of the top steroid manufacturers and our services include:
- Derivatives of steroids viz., peptides, small molecules, carbohydrates, and methoxy PEGs
- Process optimization and robust development of multi-step organic synthesis
- Handling of organometallic reagents, oxidations, reductions, hydrogenations, protection-deprotection and cryogenic reactions
- Analytical support for development, impurity profiling and characterization based on spectral methods
- Regulatory filings
Steroid Manufacturing Facility: World-class Infrastructure to Support Steroid Manufacturing
Our facility in Cuernavaca, Mexico is a US FDA-inspected site with a legacy of manufacturing 15+ steroidal APIs and intermediates. The manufacturing building* (bays) for steroids are dedicated and physically separated from non-steroid production bays.
- Steroids are manufactured in Mexico using dedicated blocks
- Multiple modules for manufacturing
- Mix of SS, GL and Hastelloy reactors
- State-of-the-art clean room facilities
- Electronically controlled pressure differentials and airlock systems
- Decontamination rooms for personnel and product containers, containment for offloading and milling
- State-of-the-art reaction system to handle cryogenic reactions below -150 ºC
- HVAC systems for steroids buildings are also separated systems from non-steroids buildings
- Highest international HS and E Standards are applied in manufacturing areas
- Warehousing: we have dedicated warehousing that is physically segregated with independent HVAC for storage of steroidal RMs, intermediates, and APIs
- Strict procedures (full cGMP’s internal SOPs) are followed for materials handling in warehouses and dispensing areas
- Utilities like nitrogen and water that has direct contact with raw materials or products are separate for steroidal as well as non-steroidal block
- Specifications, analytical methods, analytical records, and SOPs are in place for the quality management of all materials in full compliance
- We have a highly experienced team of chemists, analysts, and process engineers. Personnel in manufacturing areas are well trained and qualified for operating both steroidal and non-steroidal processes
Why Aurigene Pharmaceutical Services?
20+ years of legacy
End-to-end services from lab to plant
Dedicated US FDA inspected site
Highly experienced team of chemists, analysts and process engineers
Highest standards of digital control systems at the site
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Pharmaceutical Analytical Services
Polymorph Screening
ADME/DMPK Services
Drug Formulation Services
In vivo Pharmacology
Medicinal Chemistry
Microbiology Testing
Peptide Synthesis
Development and Kilo Lab
Toxicology Studies
Contact Us
Resources
JUNE 28, 2022
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
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Technology meets sustainability - How a complex API development process goes green
We 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. ...
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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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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2021
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
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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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Simple and efficient synthesis of imidazoquinoxalines and spiroquinoxalinones via pictect-spengler reaction using Wang resin, Synthetic Communications
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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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Frequently asked questions
What experience does Aurigene have in the development and manufacturing of steroids?
Aurigene has an extensive experience in the development and manufacturing of steroids. This includes process development, optimization, analytical development and manufacturing. The development labs are equipped to handle steroids and there are dedicated facilities used for the manufacturing. The manufacturing facilities are audited and approved by regulatory bodies.
What capabilities does Aurigene offers in the safely handling and the development of steroids?
Aurigene has dedicated facilities for development and manufacturing, this ensures safe handling of the steroids, determination of trace levels of steroids followed by safe disposal of waste streams.
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