Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
List view / Grid view
Active Pharmaceutical Ingredient (API)
Filter the results
US-based Novadoz Pharmaceuticals has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
Discover why we’re the partner of choice for exploring new developments using animal-derived APIs.
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
Included in this in-depth focus are articles on using vitamins and fatty acids as APIs as well as the trends that have influenced the global excipients market.
According to research from the Indian Pharmaceutical Alliance, the country’s pharma sector has capacity to grow. This article investigates some of the goals, challenges and proposals the report sets out for the industry.
Custom manufacturing of specialty chemicals and APIs.
New chemical entities are largely insoluble, which creates a significant challenge when formulating new drugs; but scientists have recognised the potential of metal organic frameworks (MOFs) as alternative delivery mechanisms for such drugs.
The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.
Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes
Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.