Pharmaceutical Technology Sourcing and Management Monthly Issue:
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Pharm Tech
September 2016
Volume 11 Issue 9
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In This Issue

API Synthesis and Manufacturing
Supply Chain Update
Outsourcing Update
Contract Services Update

In the Lab

Putting Shelf-Life to the Test

Contract test labs recommend best practices for effective stability testing for drug products.
/ read more /

Quality Issues Cited at Frontida BioPharm

FDA issued a warning letter to the company for quality control violations.
/ read more /

Zhejiang Medicine Receives FDA Warning Letter

The Chinese facility was cited for data integrity violations.
/ read more /

Automated Infrared Microscope Effectively Analyzes Micro Samples

The AIM-9000 infrared microscope contains automated analysis functions and a wide-field camera option.
/ read more /

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Copley Scientific Launches Products for Tablet Dissolution Testing

Copley announced that it has launched new dissolution testing equipment.
/ read more /

Eppendorf Expands Single-Use Vessel Portfolio

The company announced that it will be expanding its portfolio of single-use vessels for fermentation.
/ read more /

PANalytical launches the Empyrean Nano edition

The Empyrean Nano edition offers a combination of advanced X-ray scattering techniques.
/ read more /


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API Synthesis and Manufacturing

The Enzymatic Catalysis Route to Going Green

Drug companies and CDMOs seeking greener routes to the production of complex APIs may look to biocatalysis.
/ read more /

Fuji Health Changes Name to Fuji Chemical Industries USA, Inc.

API and drug product manufacturer changes name to align with parent company.
/ read more /


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FDA Releases Guidance on Co-Crystal Classification

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
/ read more /

Piramal to Acquire HPAPI CDMO Ash Stevens

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.
/ read more /

Agilent Plans Expansion of Oligo Manufacturing Capacity

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.
/ read more /


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Supply Chain Update

CSafe Acquires Kallibox

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.
/ read more /

Group Reports Progress on an Open Serialization Communication Standard

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.
/ read more /

TruTag Technologies' Manufacturing Plant Achieves GMP Compliance

The GMP-certified facility will produce TruTag microtags for global pharmaceutical customers.
/ read more /


Outsourcing Update

CMOs Step Up to Test New Bioprocessing Technology

CMOs experiment with new filtration and purification methods to alleviate downstream bottlenecks and stay competitive.
/ read more /


Contract Services Update

SGS Opens New Facility in Wiesbaden, Germany

The new facility is solely dedicated to offer extractables and leachables (E&L) testing services to the pharmaceutical and related industries.
/ read more /

CordenPharma in France Reports Successful FDA Inspection

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.
/ read more /

Regis Technologies Reports Successful FDA Inspection

FDA found no observations during recent inspection of Regis Technologies manufacturing site.
/ read more /

Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
/ read more /

Recipharm Expands Lyophilization Capacity in Italy

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.
/ read more /

Alcami Expands US API Capacity

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility..
/ read more /

Fresenius Kabi Expands US Sterile Injectables Capacity

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.
/ read more /


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