September 2016
Volume 11 Issue 9 |
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In the Lab
Contract test labs recommend best practices for effective stability testing for drug products.
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FDA issued a warning letter to the company for quality control violations.
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The Chinese facility was cited for data integrity violations.
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The AIM-9000 infrared microscope contains automated analysis functions and a wide-field camera option.
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Copley announced that it has launched new dissolution testing equipment.
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The company announced that it will be expanding its portfolio of single-use vessels for fermentation.
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The Empyrean Nano edition offers a combination of advanced X-ray scattering techniques.
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API Synthesis and Manufacturing
Drug companies and CDMOs seeking greener routes to the production of complex APIs may look to biocatalysis.
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API and drug product manufacturer changes name to align with parent company.
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The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
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Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.
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Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.
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Supply Chain Update
CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.
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The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.
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The GMP-certified facility will produce TruTag microtags for global pharmaceutical customers.
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Outsourcing Update
CMOs experiment with new filtration and purification methods to alleviate downstream bottlenecks and stay competitive.
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Contract Services Update
The new facility is solely dedicated to offer extractables and leachables (E&L) testing services to the pharmaceutical and related industries.
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The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.
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FDA found no observations during recent inspection of Regis Technologies manufacturing site.
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Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
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Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.
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CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility..
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Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.
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