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Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
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Active Pharmaceutical Ingredient (API)
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Heart drugs free from carcinogens identified as recalls drag on
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
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Whitepaper: The performance of PROSOLV® EASYtab SP in four medium-dose
In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs. Each of the selected APIs presented a particular challenge in terms of producing tablets with suitable hardness, weight, uniformity, content uniformity and/or reliable dissolution profiles.
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CPhI North America: FPS confirm their presence for 2019
FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions (sterile and highly toxic API)...
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New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
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Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
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Interphex New York: FPS confirm their presence for 2019
FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions (sterile and highly toxic API)...
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Flyer: Sterile manufacturing – finished dosage forms
Eurofins CDMO provides a wide range of aseptic processing services for all drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes to help develop your Active Pharmaceutical Ingredient or bulk product into Finished Dosage Forms for use in clinical…
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Global APIs market predicted to reach $245.2 billion by 2024
Major factors driving the growth of the global APIs market are thought to be the increasing incidence of chronic diseases, growing importance of generics, and the increasing uptake of biopharmaceuticals...
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Tailor-made excipients, developed the Kolb way
Standard excipients can be sourced from various suppliers, but what if you need to customise an excipient to suit your needs?
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Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
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Application Note: Verification of three different Opadry whites using a handheld Raman analyser
Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.
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Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
