Small Molecule CDMO Services
Driven by
efficiency, safety, and scalability
25+ Years of
Expertise
19 NCEs
commercialized
16 USFDA approved
cGMP facilities
Our small molecule manufacturing capabilities
Our specialized units provide cutting-edge capabilities, including cryogenic reactions, high-potency molecule handling, and high-pressure synthesis. We ensure precision and safety in complex chemical processes with dedicated blocks for steroids, peptides, continuous manufacturing, and PEG derivatives.
Our FDA-approved cGMP facilities offer comprehensive contract manufacturing services for intermediates and APIs, supporting clinical and commercial stages. The facilities feature over 4,100 m3 of reactor capacity and produce more than 2,100 MT of APIs annually, ensuring scalability and full compliance with global pharmaceutical standards.
The various specialized chemistry CDMO technologies we serve are
Write this in five lines. We have 15+ years of experience with Methoxy Polyethylene Glycol (mPEG) and activated mPEG development and manufacturing. We perform mPEG development at our R and D center in Hyderabad. Our team has extensive experience in synthesis, analysis, purification and troubleshooting of mPEG derivatives and have technical capabilities in synthetic route design to incorporate various activating groups and help customize products as per end applications.
Aurigene is a leading manufacturer and supplier of Methoxy Polyethylene Glycol (mPEGs) and activated Methoxy Polyethylene Glycol (mPEGs) which are used for the conjugation of proteins, antibody fragments and peptides. With our GMP manufacturing capabilities and backward integration to highly pure Methoxy PEG-OH, we guarantee the quality and security of the supplies of our activated Methoxy PEGs (mPEGs) products. As a leading CDMO, we understand customer requirements and customize our products to meet the client’s requirements. Currently, we serve multiple customers in various products such as diagnostic players, other mPEG suppliers, and big pharma using mPEG for advanced therapeutics. In addition, our backward integration of key raw materials makes it possible to ensure a sustainable quality of the final activated mPEG throughout the manufacturing process. We have technical capabilities in synthetic route design to incorporate the activating group and help customize products as per end applications. Our centers at Hyderabad and Mirfield are equipped with advanced instruments to enable the scale-up of activated mPEG production up to 90 kg per batch. Successful custom PEGylation requires several factors to be optimized such as the site of PEGylation, chain length, and mPEG linkers. Determining the optimum mPEG may require the testing of several activated mPEGs at different chain lengths. We offer a range of activated linear mPEGs to enable our customers to find the ideal mPEG for conjugation of the required quality, with high levels of activation, narrow polydispersity and low diol content.
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.
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.
We have a strong track record in process optimization and robust process development of peptide molecules. Our team is highly experienced in handling all forms of peptide synthesis viz. solid, solution or hybrid phase peptides at our R and D centers in Hyderabad and Bangalore.
We have a dedicated peptide lab to support peptide synthesis, downstream purification, isolation and lyophilization.
As one of the leading CDMO, we have a state-of-the-art analytical laboratory for impurity characterization and profiling based on spectral methods.
We have one of the largest facilities to manufacture high-throughput synthesis of a wide variety of standard and complex peptides. We can manufacture various types of peptide classes with linear peptides up to 40 AA, conjugates of peptides such as small molecules, lipids, carbohydrates, and PEG. Cost effective LPPS approach for small peptides or linkers. We have expertise in process optimization and robust development for commercial manufacturing.
Our advanced technology with modern infrastructure enables us to produce up to 2 kg of linear and branched chain peptides. We provide peptide manufacturing services from our state-of- the-art manufacturing site in Vizag. The site is inspected by major regulatory bodies such as the US FDA, MHRA, and PMDA
While carbohydrates have the potential to develop various therapeutic drugs, there is an inherent structural complexity in developing these molecules. At Aurigene, we have a rich track record of having worked on all classes of carbohydrates such as Monosaccharides, Polysaccharides, Iminosugars, Carbocyclic sugars, Nucleosides, Locked nucleic acids (LNA), Glycopeptides, and Thioglycosides. We have capabilities across complex multi-step carbohydrates involving linear and convergent synthesis,
Selective protection and deprotection, control of selectivity in moisture-sensitive glycosylation, handling of triflates, azide transfer, and oxidations. We also have hands-on experience in the use of glycosyl donors like SMethyl and STolyl and have capabilities in downstream purification and isolation involving water-soluble intermediates.
The Aurigene expertise
Aurigene Pharmaceutical Services offers a wide array of manufacturing services to biotechnology, pharmaceutical, agrochemical and specialty chemical firms. We provide clinical and commercial supplies of APIs through our 16 US FDA-inspected cGMP manufacturing sites across India, UK and Mexico. We operate thousands of kilo liters of reactor volumes with thousand-plus reactors in intermediate blocks and clean rooms out of which hundreds of reactors can cater to special technologies like High Potent APIs, Peptides, Steroids and Prostaglandins. All our plants are operated by cGMP and regularly inspected/audited by international authorities and customers.
We offer manufacturing services in wide range of scales and are expanding our capabilities while maintaining high safety standards. Our facilities are operated with sustainability as one of the focus areas with principles around
environmental and social governance intact. Operations of our sites are linked with processes around: Green Chemistry, waste minimization, waste management, water neutrality, emission control, reducing carbon footprint and usage of renewable power, people practice, community development activities, and a strong focus on ethics compliance and transparency.
Years of
Expertise
- 400+ projects from more than 100 global customers
- 700+ dedicated scientists
- End-to-end regulatory support
USFDA approved
cGMP facilities
India | UK | Mexico
- 4100+ m3 capacity
- 1250+ reactors, including 100+ reactors with containment facility
- 5000+ MT of intermediaries manufactured per annum
- 2100+ MT of APIs manufactured per annum
NCEs
commercialized
- 15+ dedicated labs for process development along with analytical center of excellence
- Dedicated production blocks for peptides, continuous manufacturing, steroids, and PEG alcohol and derivatives
- Cryogenic reaction, High Potent and High-pressure reaction capabilities
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.
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market