Vetter Commercial Manufacturing
As a provider in the field of pharmaceutical contract manufacturing, we use our expertise in aseptic filling and the knowledge of international requirements.
As a premier provider in the field of pharmaceutical contract manufacturing, we use our expertise in aseptic filling and extensive knowledge of international requirements to enable your product to meet the most demanding quality standards.
For more than 25 years, Vetter has been producing aseptically prefilled drug- delivery systems – among them standard syringes, cartridges, vials and our patented Vetter dual-chamber systems. We have extensive experience manufacturing sensitive, high-value biologics and aseptic suspensions. To date, Vetter has helped more than 25 client products achieve FDA approval. Services include clinical manufacturing and commercial-scale production. Our processes and the products we manufacture are in compliance with european cGMP standards and FDA guidelines. Our aseptic filling technologies and methods, such as use of Restricted Access Barrier Systems (RABS), are among the most advanced in the pharmaceutical contract manufacturing industry.
Our comprehensive service includes labeling and packaging of syringes, cartridges and vials. We perform 100% inspections of all printed packaging materials using automated vision systems. We offer precision application of graduated labels, blister packaging, automatic loading of blisters and cartons, and assembly of tamper-evident closures and needle-stick-prevention safety systems. Our new secondary packaging facility provides state-of-the-art utilities and, when required, we can meet stringent Japanese standards. Vetter’s secondary packaging options include patient-friendly features, along with tamper-evident and measures for anti-counterfeiting systems.
Our analytical quality control measures include testing raw materials, packaging materials, bulk solutions, in-process materials and finished products. We also perform stability testing. Our utilities, cleanrooms and processes are routinely monitored. Our personnel are trained in the state-of-the-art analytical techniques.
In addition to aseptic filling, we provide regulatory support that extends beyond a drug’s approval. Aside from standard activities, we help clients with special regulatory needs, such as change announcements or preparation of variation documentation. Vetter offers regulatory consulting services and can develop annual product reviews in accordance with EMA / FDA requirements.