At Aurigene Pharmaceutical Services, manufacturing of both Drug Substance (DS) and Drug Product (DP) are done on site. Clinical and commercial manufacturing of DS is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single use technology. Integrated fill finish line can package the product in vials, PFS and cartridges.
The manufacturing is supported by in house physiochemical and bio analytical development. The development and manufacturing is supported with utility blocks, warehouse spaces and R and D labs. We are well equipped with WHO-GMP qualified plants. We have GMP approvals from various leading agencies including PIC/S authorities. Our facility is well equipped with state-of-the-art facilities and high throughput instrumentations like ClonePix, Octet, CEDEX, Maxcyte, Ambr etc.
For Faster Execution of Engineering Batches
We have Non-GMP manufacturing capability in the range of 50L – 200L and GMP manufacturing capability over a wide scale - 50L to 2,000L in single use bioreactors. We offer technological flexibility – Batch, Fed Batch, Perfusion in single use or stainless-steel reactors.
Manufacturing Systems
We provide Integrated approach to Safety and Quality management systems, leveraging a pan- organizational experience.
Aurigene is one stop shop across the product fife cycle – proof of concept to commercial. We can support large scale vaccine manufacturing – 2x1KL per batch run in single use platform.
We are committed to data integrity and reliability based on digital data recording in accordance with GAMP 5 requirements. We follow documentation and report writing to comply with regulatory filing with FDA, PMDA and EMEA. Our development is supported by digital infrastructure.
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.
Learning Resources
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID-19 treatm...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role in enabli...
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Overcoming challenges with cyclic peptides for In-vitro experiments and Bioanalysis
Project Requirement:Cyclic peptides were to be analyzed for Kinetic solubility, Chrom Log D, MDCK, PAMPA, & Caco2 experiments, while overcoming the challenges associated with the impact of cyclization of peptides on in vitro experiments and bioanalysisWhat were the challenges!1. Nonspecific Binding (NSB)2. Precipitation of peptides while spiking DMSO stock to...
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Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
2025
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
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Development of novel paullone-based PROTACs as anticancer agents
2025
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
2025
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2024
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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Dr. Reddy’s Laboratories, Aurigene Pharmaceutical Services, and Kainomyx announce potential partnership for joint development of affordable anti-malarial drug
2024
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), and its CRDMO arm Aurigene Pharmaceutical Services Limited (Aurigene), today announced that they have signed a non-binding Memorandum of Understanding (MoU) with Kainomyx, Inc., a US-based company with ...
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Aurigene Pharmaceutical Services Limited, a global CRDMO, and Edity announce a strategic collaboration in cell therapy
2024
Aurigene Pharmaceutical Services Limited (Aurigene), a global contract research, development, and manufacturing services organization (CRDMO), will provide discovery services to Edity Therapeutics Limited (Edity) in cell therapy. Dr. Reddy’s Laboratories Limited, Aurigene’s parent company, recently made a strategic investment in Edity, a biotechnology company...
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Aurigene Pharmaceutical Services Limited, a global CRDMO, announces the opening of its biologics facility offering process development and clinical scale manufacturing capabilities
2024
Aurigene Pharmaceutical Services Limited (“Aurigene”), a Dr. Reddy’s Laboratories Limited company, inaugurated its biologics facility spread across 70,000 sq.ft. in Genome Valley, a bio cluster, located in Hyderabad, India. The facility is designed to serve customers with process & analytical development and small scale manufacturing of antibodies and o...
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Aurigene Pharmaceutical Services Ltd., and Vipergen announce a strategic partnership for offering DNA encoded library (DEL) screening and integrated drug discovery services
2024
Aurigene Pharmaceutical Services Ltd. (Aurigene), a global contract research, development, and manufacturing services organization (CRDMO), and Vipergen ApS, a niche small-molecule drug discovery service provider specialized in DEL technologies, entered into a strategic partnership....
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