Rentschler Fill Solutions receives open-ended GMP certification by the Austrian authority AGES

DGAP-News: Rentschler Fill Solutions GmbH / Key word(s): Regulatory Approval

27.08.2019 / 09:00

The issuer is solely responsible for the content of this announcement.


Rentschler Fill Solutions receives open-ended
GMP certification by the Austrian authority AGES

– Pharmaceutical manufacturing license and GMP compliance of the Rentschler Fill Solutions plant reconfirmed by the Austrian Agency for Health and Food Safety (AGES)

Rankweil, Austria, August 27, 2019 Rentschler Fill Solutions GmbH, a contract development and manufacturing organization (CDMO) and expert for aseptic filling and finishing of biopharmaceuticals, received notification from the Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, AGES) that the pharmaceutical manufacturing license for the European market and the certificate for GMP conformity will be extended for an unlimited period of time.

Rentschler Fill Solutions 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 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 their clients in supplying vital drugs to clinics and patients.

Onsite, at the fully dedicated contract development and manufacturing organization, 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 lyophilization capacity of 15m². 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.

About Rentschler Fill Solutions GmbH

Rentschler Fill Solutions GmbH, located in Rankweil, Austria, is a contract development and manufacturing organization (CDMO) for the aseptic filling of liquid and lyophilized pharmaceutical and biopharmaceutical products. With their complete focus on clients’ projects, the company provides state-of-the-art facilities which comply with the latest regulatory, quality and safety standards. Rentschler Fill Solutions focuses on delivering small to medium-sized batches, up to 60,000 vials, to meet clinical and market needs with its highly scalable solutions. Owned by the Rentschler family, Rentschler Fill Solutions is a company with a highly skilled team offering extensive experience and reliable services in aseptic filling.
For further information, please visit www.rentschler-fill-solutions.com.

About the Austrian Agency for Health and Food Safety (AGES)[1]

The Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, AGES) is owned by the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection and the Austrian Federal Ministry for Sustainability and Tourism. AGES provides professional and independent scientific expertise in questions relating to public health, animal health, food safety, medical and drug safety, food security and consumer protection. More information can be found here: www.ages.at.

Contact:
Rentschler Biopharma SE

Dr. Cora Kaiser
Senior Director Corporate Communication
Phone: +49-7392-701-874
E-mail: communications@rentschler-biopharma.com

Media Inquiries:
MC Services AG

Eva Bauer
Phone: +49-89-210228-0
E-mail: rentschler@mc-services.eu

[1] Adapted from https://www.ages.at/en/ages/basics/


27.08.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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