European Pharmaceutical Review
APRIL 9, 2024
Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The company employs more than 6,500 people, generating revenues of €1.1
European Pharmaceutical Review
OCTOBER 12, 2023
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.
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Quality Matters
SEPTEMBER 15, 2023
PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., kristine.gates… Fri, 09/15/2023 - 11:57 Supply Chain
FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
Quality Matters
MAY 17, 2023
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.
GMPSOP
MAY 26, 2023
Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.
GMPSOP
MAY 26, 2023
Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.
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