Anzeige
Mehr »
Login
Donnerstag, 28.03.2024 Börsentäglich über 12.000 News von 687 internationalen Medien
Spezial am Donnerstag: Rallye II. - Neuer Anstoß, News und was die Börsencommunity jetzt nicht verpassen will…
Anzeige

Indizes

Kurs

%
News
24 h / 7 T
Aufrufe
7 Tage

Aktien

Kurs

%
News
24 h / 7 T
Aufrufe
7 Tage

Xetra-Orderbuch

Fonds

Kurs

%

Devisen

Kurs

%

Rohstoffe

Kurs

%

Themen

Kurs

%

Erweiterte Suche
Dow Jones News
114 Leser
Artikel bewerten:
(0)

Rentschler Fill Solutions starts GMP operations with pharmaceutical Manufacturer's Authorization granted from Austrian authority AGES

Dow Jones received a payment from EQS/DGAP to publish this press release.

DGAP-Media / 2018-10-01 / 10:00 
 
*Rentschler Fill Solutions starts GMP operations with pharmaceutical 
Manufacturer's Authorization granted from Austrian authority AGES* 
 
*- Certificate from AGES, the Austrian Agency for Health and Food Safety, 
endorses GMP conformity to Rentschler Fill Solutions' new top-of-class 
facility. * 
 
*- Aseptic filling and freeze-drying under GMP certification in operation 
since August 2018. * 
 
*Rankweil, Austria, October 01, 2018* *-* Rentschler Fill Solutions GmbH, a 
contract development and manufacturing organization (CDMO) and expert for 
aseptic fill and finish services, obtained the certificate of GMP compliance 
and the pharmaceutical manufacturing license for the European market from 
the Austrian Agency for Health and Food Safety _(Agentur für Gesundheit und 
Ernährungssicherheit, _AGES_)_ on August, 20. 
 
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. With 
construction finished in the record time of only two years and the AGES GMP 
certification, Rentschler Fill Solutions is now a full player in the fill 
and finish services market, conveniently located in the heart of Europe. 
Already, several GMP batches have been produced for customers, utilizing 
advanced aseptic filling technologies. 
 
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. 
 
"Rentschler Fill Solutions is a modern, forward-thinking fill and finish 
specialist with a high level of experience and process know-how, through 
every stage from the first clinical phases through commercial excellence. By 
designing the best and most efficient solutions for each drug product, we 
support our customers in achieving their goals," said Reinhold Elsaesser, an 
Executive Manager of Rentschler Fill Solutions. 
 
Together with the strategic partners Rentschler Biopharma SE and Leukocare 
AG, Rentschler Fill Solutions offers end-to-end services - from formulation 
development through drug substance production to aseptic fill and finish, 
all from a single source. 
 
"Our joint promise '_one contact - one contract - one quality_' represents 
our commitment to meet our clients' product and safety requirements and to 
create the potential for expedited market entry. The combination of our 
reliable technology and customer-oriented processes with the international 
experience of our experts, enables us to satisfy the high expectations of 
our customers and power their progress," Mr. Elsaesser added. 
 
Rentschler Fill Solutions invites you to visit the company at the CPhI 
Worldwide conference in Madrid, October 9th-11th, 2018 at the joint booth of 
Life Sciences Austria (ICSE hall 3, booth 3D73). For more information, 
please visit www.cphi.com/RFS [1]. 
 
*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 [2]. 
 
*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 [3]. 
 
*Contact:* 
 
*Rentschler Fill Solutions GmbH* 
Andrea Kitzelmann 
Expert Marketing 
andrea.kitzelmann@rentschler-fill-solutions.com 
 
*Media Inquiries:* 
 
*MC Services AG* 
Dr. Cora Kaiser / Jessica Breu 
+49-89-210228-0 
rentschler@mc-services.eu 
 
[1] Adapted from https://www.ages.at/en/ages/basics/ 
 
End of Media Release 
 
Issuer: Rentschler Fill Solutions GmbH 
Key word(s): Health 
 
2018-10-01 Dissemination of a Press Release, 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. 
Archive at www.dgap.de 
728961 2018-10-01 
 
 
1: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=f20736348a77a2902b70791d6ff5395d&application_id=728961&site_id=vwd&application_name=news 
2: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=c10d5f3752fb063774c94f2fb4a2e1f9&application_id=728961&site_id=vwd&application_name=news 
3: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=8fb099fcc8f0f42d8ee2da4af03aa088&application_id=728961&site_id=vwd&application_name=news 
 

(END) Dow Jones Newswires

October 01, 2018 04:00 ET (08:00 GMT)

Großer Dividenden-Report 2024 von Dr. Dennis Riedl
Der kostenlose Dividenden-Report zeigt ganz genau, wo Sie in diesem Jahr zuschlagen können. Das sind die Favoriten von Börsenprofi Dr. Dennis Riedl
Jetzt hier klicken
© 2018 Dow Jones News
Werbehinweise: Die Billigung des Basisprospekts durch die BaFin ist nicht als ihre Befürwortung der angebotenen Wertpapiere zu verstehen. Wir empfehlen Interessenten und potenziellen Anlegern den Basisprospekt und die Endgültigen Bedingungen zu lesen, bevor sie eine Anlageentscheidung treffen, um sich möglichst umfassend zu informieren, insbesondere über die potenziellen Risiken und Chancen des Wertpapiers. Sie sind im Begriff, ein Produkt zu erwerben, das nicht einfach ist und schwer zu verstehen sein kann.