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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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Continuous Flow Chemistry: A Game-Changer for Pharmaceutical Production

Continuous Flow Chemistry: A Game-Changer for Pharmaceutical Production

Fig 1:Schematic diagram of continuous flowFlow chemistry, also known as continuous flow chemistry, involves the continuous movement of reactants through a reactor to produce products. Unlike traditional batch chemistry, where reactants are mixed in a single vessel and processed in discrete batches, flow chemistry uses a continuous stream of reactants and intermed...

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CDMO white paper

Advancement in personalized medicine and how the CRDMO industry is part of the solution

Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role in enabli...

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Anti-infective drug discovery

Anti-Infective Drug Discovery

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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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets

2024

Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...

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