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India’s lax oversight of pharmaceutical manufacturing imperils health around the world

STAT

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.

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Key developments in pharmaceutical manufacturing – September 2023

European Pharmaceutical Review

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Research by the Confederation of British Industry (CBI) , released in September this year, highlighted progress for UK manufacturing in its latest Industrial Trends Survey. Meath opened last month.

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STAT+: Biden invokes Defense Production Act to stem drug shortages

STAT

WASHINGTON — President Biden is using a Cold War-era law to stem drug shortages by boosting domestic pharmaceutical manufacturing. Biden announced the initiative at the first meeting of his supply chain resilience council.

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Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water

European Pharmaceutical Review

In conclusion, because there is “so little nitrite in purified water” using it in drug substance manufacturing processes, “even under acidic conditions and in the presence of vulnerable amines, does not constitute a nitrosamine presence risk for the product in most cases”. The paper was published in Organic Process Research & Development.

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STAT+: FTC says pharmacy benefit managers are stonewalling requests for information

STAT

Over the past several years, though, these companies have come under increased scrutiny amid concerns that a lack of transparency into their dealings with pharmaceutical manufacturers and state Medicaid programs has driven up health care costs for consumers as well as taxpayers.

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Sustainability in Pharmaceutical Manufacturing

PharmaTech

Pharmaceutical Technology spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.