Aurigene Pharmaceutical Services is a global Contract Research, Development, and Manufacturing Organization (CRDMO). Built on the legacy of accelerating innovation and backed by a vast track record in drug discovery, development, and manufacturing of both small and large molecules.
We specialize in providing integrated and standalone services for discovery chemistry, biotherapeutics discovery, discovery biology, development, and manufacturing services for clinical phase I-III programs, regulatory submission batches, and commercial manufacturing.
Our mission is to work for the success of our customers relentlessly and to build long-term relationships through a holistic approach to accelerate the journey of a molecule from the laboratory to market.
In Small molecule Manufacturing, Aurigene sets itself apart with its integrated API and formulations service that spans from key starting material, advanced intermediates, and APIs to finished products such as oral solids, sterile products, parental, topical etc., We provide clinical supplies and commercial supplies of APIs through our 8 US FDA-inspected cGMP manufacturing sites located 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 (HPAPIs), mPEG, Peptides, Steroids and Prostaglandins. All our plants are operated by cGMP (ICH Q7a) and regularly inspected/audited by international authorities and customers.
In Biotherapeutics Manufacturing, We provide high-quality and flexible scale development and manufacturing services for Biotherapeutics and Cell and Gene Therapy (CGT). Our capabilities include monoclonal antibody (mAb) and protein therapeutics development supported by in-house physiochemical and bioanalytical development, with a state-of-the-art cGMP viral vector manufacturing facility underway. We provide both GMP and non-GMP manufacturing services for preclinical development as well as GMP operations to support clinical or commercial needs for any recombinant protein expressed in suspension mammalian culture or E. coli.
Quality and Infrastructure: 2 R&D centers All our labs are GLP approved; 8 FDA inspected cGMP sites, AAALAC accredited vivarium Our manufacturing plants are regularly audited by US FDA, EDQM, KFDA (Korea), MHRA (UK), PMDA, SFDA, CDSCO, DMA, TGA, WHO GMP and COFEPRIS.
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