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Small Molecules: Manufacturing

Small Molecules: Manufacturing

We are committed to provide high-quality and phase appropriate manufacturing services for small molecules.

We provide clinical supplies 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 (HPAPIs), Peptides, Steroids and Prostaglandins. All our plants are operated by cGMP (ICH Q7a) and regularly inspected/audited by international authorities and customers.

We offer manufacturing services in a wide range of scales and are expanding our capabilities while maintaining high safety standards. With Electronic Batch Production Record (EBPR) and Electronic Lab Notebook (ELN), we are expanding our digitalization functionality.

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.

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Why Aurigene Pharmaceutical Services?

20+ years of legacy, worked on 500+ molecules, 15+ commercialized

Plants across continents (India, UK, Mexico)

Global regulatory inspections (USFDA, PMDA, EDQM, MHRA etc.)

Wide range of technologies & niche reactions (Peptide, Steroid, High potent)

High quality and flexible scale production

Extensive process safety and hazard analysis

Integrated QC testing and release

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JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

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Technology meets sustainability - How a complex API development process goes green

We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...

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2023

Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

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