Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
Cohort composition spans sterile small molecules, APIs, commercial cell-culture biologics, rare-disease drug substance, and CGT capacity across NY, NJ, IN, and NC manufacturing hubs. Eligibility ...
The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain. Documentation reliability across CDMOs, ...
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US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...
FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...
The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems. Shellac is a polymer used in coating applications to provide various functional ...
As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...
In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...
A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...
The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient ...
High-concentration injectable formulations present unique challenges. Poor solubility issues are often associated with small-molecule APIs formulated for oral administration. Solubility is also ...