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There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
Hosted online from 11 – 12 November, Chemspec Digital 2020 provides an interactive networking event for the fine and speciality chemicals community. From all over the world, industry experts will have the opportunity to meet, conduct business, discover innovative substances and learn about the latest trends and developments.
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
A report has said that the highly potent compound market will grow to be worth $32,200 million by the end of 2026.
Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
A new report has said that a quarter of drugs globally are based on highly potent active pharmaceutical ingredients.
The development of a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing facility has been completed in the US.
A new HPAPI manufacturing unit has been opened in France, with the capability to make a contraceptive with a superior safety profile and high level of biodegradability.
The expansion will be specifically designed to manufacture high-potency active pharmaceutical ingredients (HPAPIs) and complex antibody-drug conjugates (ADCs).
Michael Sassano from Somai Pharmaceuticals and Solaris Farms discusses the US and European markets for growing and extracting cannabinoids for the pharmaceutical industry.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
A report suggests that India’s CMO market has recently attracted investment from global private equity firms due to favourable government policies.
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
