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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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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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