March 27th 2025
In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.
February 25th 2025
EMD Millipore Provides Risk-Assessment Information for Raw Materials
September 16th 2015EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.
Key Considerations in Excipients Selection for Solid Dosage Forms
August 24th 2015Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.
Handling HPAPIs: Do Your CMOs Have the Right Stuff?
August 1st 2015Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.
Needle in the Haystack, or Rembrandt in the Attic? Drug Repurposing's New Strategy
July 31st 2015Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke