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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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“Bathtub Chemistry” - Necessity and Aspects of Process Research

MAY 19, 2023

“Bathtub Chemistry” - Necessity and Aspects of Process Research

Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they loss. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.    &nbsp...

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

 Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contract development and manufacturing organizations (CDMOs) for collaborations as they seek more adaptable capacity and c...

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How the re-designed synthesis of a complex carbohydrate can reduce cycle time

Project challenge: Complex carbohydrate chemistry involving a linear sequence of 10 chemical transformations, unstable intermediates and column chromatographic purications. Solution design: Process research and optimization was performed to develop a robust and scalable process which was implemented on commercial scale. Telescoping of reactions reduced the number...

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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug

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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