Year Founded: 1928
Number of Employees: 800+
Key Personnel: Dr. Stephan Fleck, Chief Executive Officer;
Bruno Buss, Senior Director Product Performance; Dr. Christian
Gausepohl, Senior Director Quality Unit; Gema Moreno
Cobo, Director Business Relations; Dr. Silke Huster, Director
Supply Chain Management; Dr. Kevin Kiehm, Director Product
Development; Gordon Haines, Chief Executive Officer Rottendorf
Rottendorf Pharma, a global Top 20 contract development and
manufacturing organization (CDMO), has been formulating,
manufacturing, and packaging solid oral dosage forms for
pharmaceutical clients worldwide for more than 85 years.
Its commitment to Total Process Ownership reduces clients’
management oversight requirements and costs, while improving
the supply chain and product quality. Clients choose Rottendorf
for its broad-ranging expertise, global regulatory capabilities,
commitment to quality, state-of-the art equipment and facilities,
and exceptional customer service.
Rottendorf Pharma, serves the global pharmaceutical market
—big, small, and virtual—with contract development,
manufacturing, and packing services for solid oral dosage forms.
All facilities are GMP compliant and inspected by regulatory
agencies worldwide, including the FDA, EMA, ANVISA, and
others. Rottendorf does not manufacture its own brands, and
therefore is never in competition with its clients.
Analytical development services: development, validation,
and transfer of analytical
methods; release analytics, ICH
stability studies, and analytical
support throughout the product
services: optimization, upscaling,
regulatory affairs support, and
development of granulates,
blends, tablets, capsules, film
and sugar coats, pellets, and hot
melt extrusion and granulates;
also manufacturer of clinical trial
batches for all clinical phases.
Contract manufacturing services: Available for all solid
dose forms, including high potency products. Product transfer,
validation, qualification, procurement of APIs and excipients.
Packaging services: full range—blister packs, bottles, granulate
filling, and Alu-wrap©; supply chain services for procurement of
packaging materials and distribution.
Rottendorf has state-of-the-art development, manufacturing,
and packaging facilities in Ennigerloh, Germany. The
Rottendorf Development Center provides best-in-class
technical equipment in line with GMP and FDA standards. It
produces batches from 2 kg to 150 kg. Manufacturing facilities
produce batches up to 750 kg.
As a top 20 CDMO providing analytical development, formulation
development, contract manufacturing, and packaging services to
the global pharmaceutical market, Rottendorf Pharmaceuticals
relies on a Total Process Ownership philosophy to serve our
clients. This means we assume a much higher degree of ownership
over the processes we use to bring your pharmaceuticals to
market than a typical CDMO. At Rottendorf, you are not simply
renting equipment or out-tasking. You are outsourcing critical
components of your business to a trusted partner. We bring more
than 85 years of experience, serving 200 clients and producing
more than 600 products, to each project.
Rottendorf Pharma GmbH
Ostenfelder Str 51-61
D-59320 Ennigerloh Germany
Tel: + 49 (0) 2524 2680
Key Contact and Phone: Mrs. Gema Moreno Cobo, Director Business
Relations, +49-2524-268-226 (office), +49-151-72708372 (cell)
Rottendorf Pharmaceuticals Inc.
875 North Michigan Avenue, 31st Floor
Chicago, IL 60611
Tel: (312) 794-7836
Key Contact and Phone: Gordon Haines, CEO
260-413-6114 (cell); 312-794-7836 (office)