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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). This includes risk-based identification of contamination vectors, proactive mitigation controls, and lifecycle review of effectiveness.

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

Putting Patients First Blog

33 These partnerships provide American patients with access to a wide range of critical medicines manufactured to rigorous quality standardsmedicines that complement, rather than compete with, domestic production. 2 (2022): e314e322. Journal of Oncology Practice 18, no. 6 Avalere Health, Majority of API in U.S.

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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

The FDA has an established office in India overseeing the number of qualified manufacturers supplying generic medicines to the US. It has also introduced the Foreign Unannounced Inspection Pilot programme, conducting multiple unannounced and short-term notice inspections in India since March 2022.

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Reuters Pharma 2022 – a day one overview – part 1

pharmaphorum

The Reuters Pharma event 2022 began as a bustling industry affair yesterday, based out of the Nice Acropolis convention centre on France’s balmy south coast. Indeed, of the 281 WHO-listed essential medicines, 100% of respiratory treatments are Teva’s. NB: Part 2 of ’Reuters Pharma 2022 – a day one overview’ will follow shortly….

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Inflation threatens supply of life-saving generics to Europe

Pharmaceutical Technology

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

In the judgment ‘Pharmacia & Upjohn SA vs Paranova A/S’ (CJEU judgment of 12 October 1999 in case C-379/97) 2 CJEU decided that BMS conditions apply also to the medicinal product rebranding. Four recent rulings on parallel imports In November 2022, the CJEU announced four rulings on the parallel import of medicinal products.

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Sandoz bulks up ahead of possible sale with Coalesce buy

pharmaphorum

For Sandoz, the acquisition gives it a technology platform in an area of the generic medicines market with a relatively high barrier to entry, as developing inhaled medicines poses “comparatively high technical complexity,” according to Sandoz chief executive Richard Saynor.