APSL 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&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
- Personnel: 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 & non-steroidal processes
Why Aurigene Steroid Development and Manufacturing Services?
20+ years of legacy
End-to-end services from lab to plant
Dedicated USFDA 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 & Kilo Lab
Toxicology Studies
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Resources
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Frequently asked questions
What experience does APSL have in the development and manufacturing of steroids?
APSL 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 APSL offers in the safely handling and the development of steroids?
APSL 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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