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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). Shift towards unannounced inspections: In a press release dated May 6, 2025, the U.S. Source: Ministry of Commerce & Industry, DGCI&S, 2025 4.

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A path to locally manufactured quality medicines: Building capacity in Africa to conduct bioequivalence studies

Quality Matters

Quality generics play a crucial role in increasing access to affordable and effective treatment options for many health conditions. However, assuring the quality, safety, and efficacy of generic medicines, which can be achieved through bioequivalence (BE) studies, remains a critical issue.

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NHC Submits Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients

Putting Patients First Blog

250414-0065, XRIN 0694-XC120] Dear Director Astle: The National Health Council (NHC) appreciates the opportunity to provide comments on the Bureau of Industry and Security’s Section 232 investigation into the national security implications of imports of pharmaceuticals and pharmaceutical ingredients.

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How could tariffs impact the pharmaceutical industry?

European Pharmaceutical Review

The US imports a substantial volume of APIs and finished medicines, many of which are essential for patient care, meaning these tariffs could have far-reaching implications. 1 Here, we explore the potential impact of tariffs on pharmaceutical supply chains, pricing, investment and industry strategy. Available from: [link] 2.