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API Manufacturing Infrastructure API Manufacturing Infrastructure

API Manufacturing Infrastructure

Ensuring a reliable and sustainable supply of APIs through our US FDA-inspected GMP manufacturing sites across India, UK and Mexico.

We provide clinical supplies and commercial supplies of APIs through our 8 US FDA-inspected cGMP manufacturing sites across India, the UK and Mexico. We operate thousands of kilo liters of reactor volumes with thousand-plus reactors 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. Some of the international agencies that have audited our sites include:

US FDA EDQM KFDA MHRA PMDA SFDA
CDSCO DMA TGA WHO GMP COFEPRIS

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: waste minimization, waste management, water neutrality, emission control and usage of renewable power, people practice, community development activities and a strong focus on ethics compliance and transparency.

The focus on these initiatives has been recognized by agencies such as:

DJSI (Dow Jones Sustainability Indices) FTSE4Good Index CDP (Carbon Disclosure Project) S&P BSE Carbonex S&P BSE Greenex Bloomberg Gender-Equality Index

 

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Why meet us at CPHI Barcelona?

SEPTEMBER 04, 2023

Why meet us at CPHI Barcelona?

Discover the Opportunities: Visit Aurigene Pharmaceutical Services at CPHI BarcelonaThe Contract Research, Development and Manufacturing Organization (CRDMO) industry is a dynamic and rapidly evolving sector emerging as it plays a vital role in providing a wide range of services enabling drug companies to bring their products to market efficiently and effectively...

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Immuno Oncology - Therapies and Challenges

With more than 200 distinct cancer types recognized and steady increase in cancer incidence rates, the fight with cancer takes a new shape with each emerging decade. First was surgery, followed by radiotherapy and chemotherapy. The fourth one was targeted cancer therapeutics, also known as precision therapies. Precision therapies were established with the discove...

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Anti-Infective Drug Discovery

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Objective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series.      Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...

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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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