At APSL, manufacturing of both Drug Substance (DS) and Drug Product (DP) is done on-site. The manufacturing is supported by in-house physiochemical and bioanalytical development. The development and manufacturing are supported with utility blocks, warehouse spaces, and R&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 robotics and high throughput instrumentations such as ClonePix, Octet, CEDEX, Maxcyte, and Ambr.
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 such as –
Batch Fed-batch Perfusion in single use/stainless-steel reactors
We provide an integrated approach to safety and quality management systems, leveraging a pan-organizational experience. We are a one-stop shop across the product life cycle – proof of concept to commercial.
We can support large scale vaccine manufacturing – 2x1KL per batch run in a single-use platform. Clinical and commercial manufacturing is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single- use technology.
State-of-the-art cGMP viral vector manufacturing (scales up to 2 X 1000 L) facility is being commissioned and clinical grade rAAV production process optimization is under development. 10KL of cell culture manufacturing capacity with expansion initiatives under way to double capacity by setting up a new cell culture manufacturing plant, fill finish manufacturing plant, clinical material manufacturing plant, and supporting utilities.
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.

Aurigene Pharmaceutical Services Limited is a leading contract research, development and manufacturing organization (CDMO) providing end-to-end solutions. With a strong legacy of services in discovery, development and manufacturing we are ideally positioned
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Aurigene Pharmaceutical Services Limited is a leading contract research, development and manufacturing organization (CDMO) providing end-to-end solutions. With a strong legacy of services in discovery, development and manufacturing we are ideally positioned
Know MoreWe 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.
Aurigene Pharmaceutical Services is a leader in the synthesis of activated MethoxyPolyethyleneGlycol(m-PEGs), With a comprehensive product range and customized services. ...
Read More2020
A novel approach for the spiro-isoindolinone dihydroquinazolinones has been demonstrated from 2- aminobenzamide and 2-cyanomethyl benzoate in the presence of KHMDS as a base to get moderate yields. The reaction has been screened in various bases followed by solvents and a gram scale reaction has also been executed under the given conditions. Based on the controll...
Read More2005
An improved and rapid synthesis of mefenamic acid based indole derivatives has been achieved via the ligand free Cu-catalyzed coupling-cyclization method under ultrasound irradiation. This simple, straightforward and inexpensive one-pot method involved the reaction of a terminal alkyne derived from mefenamic acid with 2- iodosulfanilides in the presence of CuI ...
Read More2005
The formal synthesis of Cladospolide-C and its analog is achieved by using enantiopure (R)-g evalerolactone 10. The significant points of this synthesis are the stereoselective dihydroxylation of a, bunsaturated ester 16 using Sharpless protocol, Wittig olefination of g evalerolactol 6 with triphenylphosphonium iodide salt 7, one pot selective oxidation ...
Read More2005
A new one pot multicomponent annulation strategy for the synthesis of various dihydroquinazolinone compounds has been developed using Amberlite-15 as a catalyst, giving good to moderate yields. In this reaction the substrate scope for amines and aldehydes was also investigated. The reaction has been checked on a large scale ...
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October 24th-26th, 2023 | Barcelona, Spain
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