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PTSM: Pharmaceutical Technology Sourcing and Management-04-01-2015
PTSM: Pharmaceutical Technology Sourcing and Management
Xcelience Receives DEA Approval for Schedule I Drug Products
March 30, 2015
Contract Services
11
4
Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.
Standard for Excipient GMPs Reflects Industry Consensus
March 30, 2015
Regulation and Compliance
11
4
A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
TraceLink Joins PBOA
March 30, 2015
Outsourcing
11
4
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
Serialization Success Depends on Integrated Equipment and Systems
March 30, 2015
Supply Chain
11
4
Implementing serialization on a packaging line requires a complex integration of hardware and software and often requires that new and existing systems work together.
Risk-based Strategies to Prevent Drug Shortages
March 30, 2015
Supply Chain
11
4
PDA’s new technical report provides a template for bio/pharma companies to follow to establish a risk-based approach to prevent drug shortages.
Shifting Biopharma Strategies Shape Outsourcing Market
March 30, 2015
Outsourcing
11
4
Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.
Temperature-controlled Logistics Address Cold-Chain Challenges
March 30, 2015
Supply Chain
11
4
Temperature-controlled packaging trends include prequalified systems that simplify adoption, reusable systems that are more sustainable, and new temperature-monitoring technology.
Who Will Staff Expanding CMO Operations?
March 30, 2015
Outsourcing
11
4
Capacity expansions require staff expansions, and skilled, experienced staff, at all levels, are simply becoming increasingly hard to find.
Kemwell’s Bangalore Facility Completes Successful FDA Inspection
March 26, 2015
Contract Services
11
4
FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.
Recipharm Delivers Serialization Solutions for Abbott in Korea
March 19, 2015
Supply Chain
11
4
Recipharm expects to be rolling out further serialization projects during 2015.
Laurus Synthesis Launches New Facility in Woburn, MA
March 19, 2015
Contract Services
11
4
The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.
International Transport for Biologic Substances Expands
March 19, 2015
Supply Chain
11
4
UPS expands its special commodities program to more countries.
Catalent Unveils New Organization to Speed Up Drug Development
March 18, 2015
Contract Services
11
4
Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.
Nanobiotix Appoints CordenPharma as Manufacturing Partner
March 18, 2015
Contract Services
11
4
The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix lead product, NBTXR3.
Dr. Reddy’s Expands Formulation Development Capabilities
March 11, 2015
Outsourcing
11
4
Dr. Reddy’s announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.