news
FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
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Active Pharmaceutical Ingredient (API)
news
Teva closes in on sale of API business TAPI
The pharma company’s plan to divest its active pharmaceutical ingredient interests was first announced in 2024.
news
Lilly to site next US manufacturing facility in Texas
The new $6.5 billion Houston site will manufacture active pharmaceutical ingredients (APIs) in support of the company’s pipeline of small molecule medicines.
news
Lilly picks Virginia for the first of its four new US manufacturing facilities
The new $5 billion manufacturing site is set to become the company’s first integrated facility for API and drug product manufacturing.
news
Trump executive order targets US pharma supply chain resilience
Calls for active pharmaceutical ingredient (API) stockpile to cover around 26 ‘critical drugs’.
news
AbbVie invests $195m to expand API manufacturing in the US
The pharma company will add to its existing Chicago site, boosting its active pharmaceutical ingredient production capacity.
news
Lilly to sell off Branchburg site as its US manufacturing plans take shape
The pharma company’s digital innovation efforts also progress with the opening of a new Hyderabad facility.
news
FDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
news
Biowaste innovation could advance green pharmaceutical production
The novel approach could reduce the industry’s reliance on fossil fuels by offering a sustainable production alternative for pharmaceuticals.
article
Qualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
article
Pharma Horizons: Formulation
European Pharmaceutical Review's latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
whitepaper
Application note: Highly efficient method development using LC-MS for automated peak tracking
Peak tracking in liquid chromatography (LC) method development can be challenging due to retention variations and co-elution. LabSolutions MD software with LCMS-2050 SQ-MS simplifies peak identification and automates method and sequence creation, enabling efficient development of reliable separation methods.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
news
Innovating small molecule injectables: market forecast to 2033
Key trends in the global small molecule injectable drugs market up to 2033 include advancements in technology, drug delivery systems and fast-track approvals of new drug formulations, research predicts.
news
Major manufacturing investment to support API production for tirzepatide
Eli Lilly and Company has committed the largest US investment in synthetic medicine active pharmaceutical ingredient (API) manufacturing.
