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October 29, 2019
The approval marks the first time a new glass composition has been approved by FDA since the approval of borosilicate glass more than 100 years ago.
October 11, 2019
AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
September 19, 2019
The company will supply its heparin sodium injection in prefilled syringe form.
September 02, 2019
Equipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.
August 21, 2019
The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.
August 02, 2019
Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.
June 24, 2019
Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.
May 15, 2019
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Empty and prefilled syringes must pass a range of quality control tests.