The Austrian Agency for Health and Food Safety has extended licence for the European market and the certificate for GMP conformity
Photo as seen on Rentscheler website
Rentschler Fill Solutions, a CDMO and specialist in aseptic filling and finishing of biopharmaceuticals, has received notification from the Austrian Agency for Health and Food Safety (AGES) that the pharmaceutical manufacturing licence for the European market and the certificate for GMP conformity will be extended for an unlimited period of time.
Rentschler offers the international biotech and pharmaceutical industry specialist fill and finish services which range from GMP-compliant aseptic filling and freeze-drying to extensive analytics.
The newly constructed, state-of-the-art facility as the centre of the licence went into operation in August 2018 and was initially certified by AGES for one year, as is common procedure. As part of a routine follow-up examination at the end of the first year of operation, the time limit has now been lifted.
This is an important milestone for the company to support its clients in supplying vital drugs to clinics and patients.
At the plant, pharmaceutical and biopharmaceutical products are filled in vials of 2 to 50 ml for clinical and commercial use. The facility is designed for the flexible handling of small to medium sized batches of up to 60,000 vials and provides lyophilisation capacity of 15 sqm.
Single-use equipment guarantees maximum product safety. Clients profit from comprehensive in-house testing, monitoring and analytics.
The facility is designed to enable future expansion without interrupting ongoing operations.