Immunoglobulin - 2
Grifols: Plasma quality from donor to finished products
Grifols immunoglobulins are manufactured from plasma originating from our own US and EU plasmapheresis centers, conforming to cGMPs, IQPP of the Plasma Protein Therapeutic Association (PPTA) and fulfilling additional requirements set by Grifols.
- Production processes and facilities are certified according to the US FDA and EU regulations
- Grifols immunoglobulins are licensed according to both USP and EP requirements
Immunoglobulins - 3
Grifols: Experts in worldwide product registration
Regulatory requirements are increasingly more stringent and consequently the process of registering therapeutic biological products is particularly complex.
As a manufacturer of biological products that are registered in many countries, at Grifols, we offer you valuable expertise in regulatory compliance around the world.
We can offer a single immunoglobulin product that complies with the regulatory requirements of multiple health authorities, allowing our customers to streamline the regulatory process.
Let us help you overcome all obstacles standing in the way of a smooth product registration around the world.
The information contained in these webpages are intended for a professional audience of pharmaceutical and in vitro diagnostic manufacturing personnel.