DEVELOPMENT OF TABLETS AND CAPSULES IN THE HIGH POTENT RANGE

We develop
and manufacture
products in line
with international
standards

for the European, US and Japanese markets, as well as for other markets around the world. We work according to Quality by Design (QbD) principles and use PAT technologies.

We have decades of experience. In the last six years alone, we have received international approval for five new molecules (NCEs) commissioned by our customers. We support our customers with the topic of life cycle management across all life phases of their products.

Dr. Georg Straller, Development and Transfer

From the clinic to
commercial production.

In 90 percent of cases, we start with development and then enter the commercial production phase, all the way through to packaging.

Dr. Georg Straller, Development and Transfer

What development
means for us

We develop formulations and processes based on our customers’ formulas. Our objective is stable and reproducible drug production. We focus on clinical phases II and III, but can also begin with phase 1 upon request. If you wish, we can transfer your existing production process directly.

Our services in the OEB 4 to 6 high potent range

Film-coated tablets, mini tablets and capsules
Batch sizes from 0.5 to 230 kg
Direct tableting, compacting, wet granulation and fluid bed granulation
Water-based coating preferred
Modified release dosage forms
Packaging in blister packs and bottles

Our services in the conventional area

Film-coated tablets and capsules
Batch sizes up to 500 kg
Direct tableting, compacting, wet granulation and fluid bed granulation
Water-based coating preferred
Modified release dosage forms
Packaging in blister packs and bottles

Dr. Anngrit Trapp, Customer Relations

We provide continuous
updates on the
development progress –

either on site or in online meetings. We meticulously document all results and conclusions and work closely with you to coordinate further development steps.

Dr. Anngrit Trapp, Customer Relations

Our guidelines
Quality by Design (ICH Q8 – 10)

ICH Q9

Toolbox

ICH Q9

Toolbox

ICH Q10

conduct commercial
manufacturing

ICH Q10

Process Change
controls

ICH Q10

respond to
deviations

ICH Q10

improve products
and processes

ICH Q8

develop new
Products (QBD)

ICH Q8

develop new
ProCESS

ICH Q8

TECH TRANSFER

ICH Q10

QUALIFY AND
Validate product
and Process

We adapt to our customers’ wishes and requirements

Whether a simple transfer or a highly complex development project pursuant to QbD principles with a risk-based approach – our long-standing experience and flexibility as a medium-sized company allow us to take on any task.

Dr. Georg Straller, Development and Transfer