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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association.

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

Express Pharma

based Bionique Testing Laboratories (2021), and biologics CDMO Bionova Scientific (2022). Our bioprocess portfolio, including recently launched Planova FG1 and THESYS SCS and ACS Columns, has received strong feedback from customers, the company stated.

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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). For instance, India’s role as a major supplier of COVID-19 vaccines underscored its capabilities in high-volume sterile manufacturing (4). and EU markets.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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Examining the One Big Beautiful Bill Act on Prescription Drugs: Benefits and Criticisms

Pharmacy Times

Pharmaceutical companies benefit from extended R&D tax incentives and reshoring manufacturing, favoring long-term investment. Critics argue the bill prioritizes pharmaceutical profits, reduces Medicare's negotiation power, and increases inequality in healthcare access. REFERENCES 1. Accessed July 17, 2025.

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Optimising customer experience in global medical information installations: Part Two

pharmaphorum

Skip to main content Wednesday 6 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)

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Pharmaceutical Manufacturing And Packaging Congress 2022 Connects Pharma Leaders

pharmaphorum

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies.