Small-Molecule APIs

Sep 01, 2015
Pharmaceutical Technology
More complex drug candidates require more specialized and selective chemistry.
Aug 02, 2015
Pharmaceutical Technology
Findings from a study on import testing, based on data collected from six multinational pharmaceutical companies, suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing and distribution standards.
Aug 01, 2015
Pharmaceutical Technology
Ignoring 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.
Jul 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
Jul 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications and the industry has only scratched the surface of what might be possible.
Jul 23, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.
Jul 22, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.
Jul 16, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.
Jul 16, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
Jul 02, 2015
Pharmaceutical Technology
FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.
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