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
Resources
MAY 19, 2023
“Bathtub Chemistry” - Necessity and Aspects of Process Research
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 lose. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.Drug discovery is a vast and ...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Expediting early development through innovative precision capsule filling technology
Introduction: Any new chemical entity (NCE) needs to undergo various stages of development such as preclinical and clinical trials before drug product is approved by regulatory agencies and available for patient. Formulations developed during early phases are simple formulations to enable phase appropriate studies like screening, dose ranging, toxicological and d...
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Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation
2008
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 ...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
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.
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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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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