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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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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

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Asahi Kasei establishes life science division to streamline bioprocess operations for pharma sector

Express Pharma

To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing.

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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.

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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).

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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog: Biosimilars

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

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CNS innovator oligonucleotide licensing value up 339% from £2bn in 2024

Pharmaceutical Technology

Both modalities have emerged as the most used platform technologies in developing oligonucleotide-based drugs for CNS disorders since 2020. ASOs accounted for more than half ($3.54 billion), while siRNAs made up more than a third ($2.51 billion) of these deals.