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Steroid Development and Manufacturing

Steroid Development and Manufacturing

Two decades of experience in steroid development and manufacturing.

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.

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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

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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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