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What Is the ICH and What Does It Do

WEBThere is a joke about the fellow who comes into the plant and says, “I’m from the government; I’m here to help you.” In an effort to help pharma, the ICH (International …

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URL: https://www.pharmamanufacturing.com/compliance/compliance-management/article/11316734/what-is-the-ich-and-what-does-it-do

Pharmaceutical Industry Basics: An Occupational Health and Safety

WEBThis article by Keith Tait of Pfizer provides an overview of drug manufacturing, but focuses on occupational health and safety issues. It was published …

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The growing benefits to reshoring pharma operations

WEBThe growing benefits to reshoring pharma operations. The need to explore the diversification of U.S. pharmaceutical supply chains and the feasibility of relocation …

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The sterile injectables quality challenge Pharma Manufacturing

WEBThe sterile injectables quality challenge. June 22, 2021. How new techniques and more versatile equipment can improve syringe inspection. Karen P. Langhauser. …

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Raising a modern pharma CDMO Pharma Manufacturing

WEBPut simply, modern therapies require modern CDMOs. The four young companies we’ve chosen to profile — ten23 health, Cellares, INCOG BioPharma …

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Minding the gap in mental health treatment Pharma Manufacturing

WEBHistoric efforts to treat mental illness often hinged on what theories were in vogue. Ancient treatments were focused on spiritual cures, involving rituals, incantations …

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The top 10 most digitally innovative pharma companies

WEBThis year marked the anticipated launch of Pfizer's 2020 collaboration with digital innovator Sidekick Health — a comprehensive digital therapeutic solution …

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Meet Haleon, GSK’s new consumer health unit Pharma …

WEBOver-the-Counter. Meet Haleon, GSK’s new consumer health unit. Feb. 23, 2022. GlaxoSmithKline is forging ahead with plans for the proposed demerger of its …

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Sanofi considers sale, spin-off, joint venture of consumer …

WEBSanofi is considering a joint venture, spin-off or outright sale of its consumer healthcare unit, according to Reuters sources. The consumer healthcare arm's revenue …

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Sanofi shares plan to spin off consumer health biz

WEBSanofi announced its intention to separate its consumer health care business, with an eye on enabling greater management focus and resource allocation to …

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TherapeuticsMD licenses women's health assets to Mayne Pharma

WEBWomen's health company TherapeuticsMD announced that it has entered into definitive agreements to license several products to an affiliate of Australia-based …

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ten23 health: Sustainable success Pharma Manufacturing

WEBWith customer demand for sterile fill-finish services increasing, ten23 health announced this past fall that it is expanding the available capacity at its Visp sterile …

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Pharma Industry Annual Product Reviews: How to Conduct an …

WEBThe GMPs necessitate annual evaluation of quality standards of a drug product to determine the need for adjustments in drug product specifications, …

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Most expensive drugs Pharma Manufacturing

WEBHemgenix, CSL Behring, hemophilia B. U.S. list price: $3.5 million. After the FDA approved the first gene therapy for adults with hemophilia B last year, it quickly …

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Key considerations for CGMP raw materials compliance

WEBUse CGMP raw materials during development to: Develop characterization analytics for key quality attributes (e.g., potency, purity) to ensure product consistency. …

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Key pharma trends in 2023 Pharma Manufacturing

WEBApril 3, 2023. The year will bring transformative change to the pharma industry. Jaswinder Chadha. 2023 is shaping up to be a transformative year for the pharma industry, even …

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How to find the right CDMO partner in pharma

WEBThe global pharmaceutical contract development and manufacturing market is projected to reach $126.6 billion by 2024 from $90.0 billion today, at a compound annual …

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Bankrupt Purdue Pharma to sell consumer health biz

WEBPurdue Pharma was granted permission in U.S. bankruptcy court to sell its consumer health business, Avrio Health, to a subsidiary of Arcadia Consumer …

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Cloud Computing in Pharma Pharma Manufacturing

WEBCloud Computing in Pharma. Oct. 20, 2015. It’s never too late to reap the benefits. Raju Singit. Pharma is known for its late adoption of new technologies. The …

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