Xcelience Receives DEA Approval for Schedule I Drug Products
Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.
Standard for Excipient GMPs Reflects Industry Consensus
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
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
Serialization Success Depends on Integrated Equipment and Systems
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
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
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
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?
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
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
Recipharm expects to be rolling out further serialization projects during 2015.
Laurus Synthesis Launches New Facility in Woburn, MA
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
UPS expands its special commodities program to more countries.
Catalent Unveils New Organization to Speed Up Drug Development
Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.
Nanobiotix Appoints CordenPharma as Manufacturing Partner
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
Dr. Reddy’s announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.
