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Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water

European Pharmaceutical Review

The authors noted that the observations were contextualised to “illustrate the amounts of nitrosamine that could be formed from process water during API and drug product manufacture”. Limiting nitrosamine formation The authors highlighted that wet granulation is commonly used to manufacture solid oral dosage forms.

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Key developments in pharmaceutical manufacturing – September 2023

European Pharmaceutical Review

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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Development of novel water-soluble inks for 3D-printed polypills

European Pharmaceutical Review

Benefits in manufacturing The authors illustrated MM-IJ3DP using a novel formulation of a soluble polymer, to enable for the first time, Noyes–Whitney release rates to be programmed and modulated through digital design and manufacture. Rivers et al. This paper features in the June 2024 issue of the journal Materials Today Advanced.

Dosage 98
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Optimising wet granulation manufacturing with advanced technologies

European Pharmaceutical Review

A paper has demonstrated a novel application of optimising processes to implement inverse design in pharmaceutical manufacturing. Machine learning techniques were assessed for use as a surrogate model to optimise a three-unit wet-granulation based flowsheet model for the manufacture of solid dosage forms. Dan et al.

Dosage 64
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WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware, US. The biopharmaceutical industry is part of Delaware’s DNA,” stated Delaware Governor John Carney.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

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).

Dosage 57
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FOPE and PharmaState Academy address HVAC Systems in pharma manufacturing

Express Pharma

On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceutical manufacturing. The session began with a keynote address by Thiru M.

Dosage 96