FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|September 1, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-09-07-2016
- Volume 11
- Issue 9
Regis Technologies Reports Successful FDA Inspection
Author(s)Pharmaceutical Technology Editors
FDA found no observations during recent inspection of Regis Technologies manufacturing site.
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Regis Technologies has announced that no Form 483 observations were issued following a recent 12-day inspection by FDA of the quality and production systems at its Chicago-area facility. The inspection was a routine quality systems inspection to support Regis’ FDA registration and ongoing manufacture of clinical and commercial APIs, according to a Aug. 25, 2016 company statement.
Regis provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies from its 36,000-sq-ft facility.
The company works with high value intermediates and APIs from process development and scale-up through validation and commercial manufacturing. The company also offers pharmaceutical regulatory support services, and access to its proprietary innovative chromatography products and services.
Source:
Articles in this issue
about 10 years ago
Putting Shelf-Life to the Testabout 10 years ago
The Enzymatic Catalysis Route to Going Greenabout 10 years ago
CMOs Step Up to Test New Bioprocessing Technologyabout 10 years ago
SGS Opens New Facility in Wiesbaden, Germanyabout 10 years ago
CSafe Acquires Kalliboxabout 10 years ago
CordenPharma in France Reports Successful FDA Inspectionabout 10 years ago
Automated Infrared Microscope Effectively Analyzes Micro Samplesabout 10 years ago
Copley Scientific Launches Products for Tablet Dissolution Testingabout 10 years ago
Eppendorf Expands Single-Use Vessel Portfolioabout 10 years ago
PANalytical launches the Empyrean Nano editionAdvertisement
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