Remove 2022 Remove Drug Development Remove Pharmaceutical Manufacturing
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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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Responsible sourcing and manufacturing: Growing towards a sustainable future with Lonza

Express Pharma

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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HPM Grows Its Ranks of Directors, Counsel, and Associates as it begins its 45th Anniversary Year

FDA Law Blog: Biosimilars

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.

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Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle

Quality Matters

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Green Chemistry in the Synthesis of Pharmaceuticals.

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Exclusive Coverage: Global PHT Expo & Summit 2023

PharmaShots

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. facility for manufacturing biologics in his presentation. Anurag continued by presenting an overview of the next-gen.

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).