Services

Outsourcing our experience and competence

Dr. R. Pfleger GmbH provides a comprehensive service package based on solid experience and technical knowledge in the field of drug research and production.

Renowned pharmaceutical companies throughout Germany regularly contract our hightech facilities to manufacture their products. They have relied on Pfleger`s competence for years.

Contact: services@dr-pfleger.de

Contract Manufacturing Services

All products listed below are manufactured according to the European Union`s GMP standards. The quality of manufacturing is assured by extensive in-process control testing and documentation.

Ointments
Batch sizes from 100 to 500 kg
Filling in cylindrical aluminium tubes, 5 to 100 g
Cartoning and leafleting

Suppositories
Batch sizes from 100 to 450 kg
PVC/PE or PVC/PVDC/PE foil forming
Capacity of up to 20000 suppositories per hour
Strips of 2 - 7 suppositories
Cartoning and leafleting

Tablets / Film-coated Tablets
Batch sizes from 100 to 600 kg
Formats from 6 to 13 mm, flat/vaulted/oblong tablets up to a length of ca. 20 mm
Computer-aided, automated tablet manufacture
Aqueous films at fractions of ca. 140 kg
Packing in PVC/aluminium blisters
Cartoning and leafleting

Granules
Batch sizes of 100 to 600 kg
Dry granules
Kneaded or spray granulation (only aquaeous solvents)

Additional specialised services include the manufacture and packaging of test and pilot batches for stability testing.

Special products for clinical testing can also be manufactured under GMP conditions, tested and packaged in a variety of different containers according to customer specifications. The corresponding documentation is prepared and delivered with the products.

Aseptic manufacturing and processing of cytostatic drugs, hormones and penicillin is not available.

Analytical Services and Other Services

Quality Control
Active ingredients, excipients, bulk materials, finished products
Identity testing
Purity testing
Content assay
Content uniformity
In vitro release

Analytical Methods
Chromatography (TLC, GC, HPLC)
Spectroscopy (FT-IR, NIR, UV/VIS)
Pharmacopoeia methods

General Analytical Services
Method development
Method validation
Planning and conduction of stability tests

Other Services
Preparation of documentation
Development of new formulations and optimization of existing ones
Preparation of laboratory samples
Planning and conducting of stability tests according to ICH-guideline
Storage of test samples under various climate conditions
Advisory services