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As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
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...
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.
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)...
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
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…
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…
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)...
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…
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...
Standard excipients can be sourced from various suppliers, but what if you need to customise an excipient to suit your needs?
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
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.
