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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 1

Express Pharma

Indian pharmaceutical companies supply more than 60 per cent of global demand for vaccines and over 40 per cent of generic medicines consumed in the United States (2). For instance, India’s role as a major supplier of COVID-19 vaccines underscored its capabilities in high-volume sterile manufacturing (4).

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

The CJEU stressed that identical medicinal products are not those that are only therapeutically equivalent (as generics are to reference products), but they should be identical in all respects. He has been advising pharmaceutical companies and healthcare providers for a number of years.