Our high level of specialization allows us to offer pharmaceutical development and manufacturing for products that require advanced technology and complex production processes, such as sterile solutions (small molecules).
Our portfolio also includes products which require careful design and assembly including medical devices and bags for blood storage and collection.
Combining the focus on parenteral with the expertise of an established pharmaceutical leader, the contract manufacturing business is agile and flexible in its service to companies outsourcing the development and manufacture of added value injectable drugs.
We specialize in small molecule intravenous solutions and offer high-quality pharmaceutical development and product manufacturing.
Grifols Partnership offers any kind of sterile solution (SVP & LVP) for injection for human or veterinary pharmaceutics, including products from our portfolio and products developed according to your needs.
SVP: small volume parenteral; LVP: large volume parenteral
Diluents for reconstitution
Because diluent is as important as your API, Grifols offers you our Water for Injection Drug Master File (DMF)
Our experience in this field along with our high level of specialization allows us to offer clients this kind of medical device. For blood banks, we produce collection, separation, storage and transfusion bags for blood components and blood bags which incorporate a filtration system. Our bags are manufactured according to GMP norms to guarantee their quality. They also adhere to the requirements of the European Pharmacopeia for the manufacture of containers for blood and biological products. These exhaustive controls guarantee high levels of quality and safety of all our products which possess the full Quality Certificate according to the European Economic Community directive 93/42/ECC for medical devices.
Polypropylene bag, flexible and transparent, specially designed for preparation, reconstitution and drug administration without the need of using needles. This access port has been specially designed with a safety valve that lets you connect a syringe to add or withdraw solution. The infusion port is a standard twist-off valve.
Laboratorios Grifols has a fully automated filling line for 2.5 ml to 50 ml and intermediate volumes designed in accordance with strict GMP requirements as well as the standards required by the FDA and the EMA.
Washing process with WFI80
Depyrogenation ensuring at least a 3 log reduction in endotoxin levels.
Filling through peristaltic pump with four vial fillers to achieve highly accurate dosing and precise timing.
Vials are laser-etched on the cap, or on the glass vial
Provides a unique identification number for every single vial
Glass vial (Type I and Type II specifications) Naturally inert material, totally transparent and recyclable 100 ml, 250 ml, and 500 ml.
Two FDA-approved sites with the ability to handle pharmaceutical products and medical devices offering different technological capabilities.
Aqueous LVP and SVP
Grifols offers you parenteral preparations containing one or more active ingredients intended for administration by injection or infusion packaged in different containers.
Grifols Partnership also develops and manufactures its own flexible bags on site to obtain a perfect match between the drug and its container. This vertical integration model enables us to control the entire process from the very start, and ensure the highest standards of quality to our customers.
Four Form-Fill-Seal lines, fully automated, have been designed to manufacture 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml, PP bags, and can be adapted to manufacture special sizes depending on customer specifications.