Our Small Molecule Manufacturing services include
Special Unit Operations
We offer a variety of diverse unit operation services to our clients suitable for a broad range of APIs. All our manufacturing facilities are equipped with handling major unit operations and some exclusive unit operations like special drying using ATFD, Spray Dryer, Column Chromatography, hydrogenation, lyophilization etc.
mPEGs Manufacturing
We have 15+ years of experience in developing and manufacturing Methoxy Polyethylene Glycol (mPEG) and activated mPEG. Our dynamic team is experienced in synthesis, analysis, purification and troubleshooting of mPEG derivatives to meet varied end applications.
Steroid Manufacturing
We have two decades of extensive experience in safely developing and manufacturing steroids from concept phase to launch in India. We also have a dedicated cGMP manufacturing facility in Mexico for manufacturing commercial quantities.
HPAPI Manufacturing
We have a legacy of manufacturing 50+ high potent compounds supported by special unit operations like micronization and spray drying. Our US FDA audited facilities are designed to give output as low as 100 gm to multi-tons. We also have 3 US FDA inspected cytotoxic GMP facilities, one of the largest capacities in Asia.
Intermediate & API Contract
We have a legacy of developing 500+ molecules, several of which are in commercial phase in highly regulated markets across the USA, Europe, Japan, etc. We extend our full assistance in the manufacturing process, starting with late- phase product from regulatory filing to the final launch, as well as cost optimization options at the patent expiry stage.
Peptide Manufacturing
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. 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. We provide peptide manufacturing services from our state-of- the-art manufacturing site in Visakhapatnam.
Carbohydrate Manufacturing
We have a rich track record of working with different classes of carbohydrates such as Monosaccharides, Polysaccharides, Iminosugars, Carbocyclic sugars, Nucleosides, Locked nucleic acids, 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.
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 8 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.
Why Aurigene Pharmaceutical Services?
18 years
of expertise
Experience gained
from 100+ discovery
programmes
World-class
infrastructure
Track record
of delivering
8+ IND candidates
Flexible working
models
Quick
turnaround
time
Capabilities to
apply multiple
modalities
Seamless integration
capabilities with
Biology as well as
CDMO services
Integrated
project
management
Expertise in
various therapeutic
modalities
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