Formula GmbH
Pharmazeutische und chemische Entwicklungsgesellschaft mbH
History, Facts and Figures
In 1995, Formula GmbH was founded as a highly innovative company focussing on the development of medicinal products.
Today, the development of medicinal products is a core business segment of Formula GmbH with the objectives of formulation of solid, semi-solid, liquid and injectable medicinal products..
Development – Manufacturing – Quality Control – Release
Pharmaceutical and Analytical Development
Development of analytical methods for drug substances and products Pharmaceutical investigations in accordance with international pharmakopoes (e.g. Pharm.Eur., USP, BP) Validation of analytical methods corresponding
Manufacturing Technology, solids
Manufacturing technology Solid formulations: Options for manufacturing: Mixing by use of a Turbula, High Sheer Mixer (Glatt) or Planet Mixer Blending of powder, granules or
Manufacturing technology, liquids, semi-liquids and injectables
Manufacturing technology Liquid, semi-solids and injectable formulations: Options for manufacturing: Liposomal systems manufactured by Ultra Turrax and/or high pressure homogenisation technology Manufacturing of emulsions by
Analytical equipment and technology
Analytical equipment and technology Analytical HPLC and UHPLC (e.g. normal phase, RP-, ion pair chromatography), Ph.Eur. – isocratic, binary and trivalent high pressure gradient systems
Technological equipment
Analytical / Technological Equipment Analytical HPLC and UHPLC (e.g. normal phase, RP-, ion pair chromatography), Ph.Eur. – isocratic, binary and trivalent high pressure gradient
Clinical Supplies
„Designed for Compliance” Conversion of the study design to optimal packaging design Packaging: Blistering, bottling in multipledose containers, blinding, visitpackages, patientkits, center-boxes, shipping-boxes Filling/aliquot of
GMP and Applicant service
GMP service Auditing of manufacturer of active pharmaceutical ingredients (API) – issuing of QP declaration(s) Auditing of manufacturer of medicinal products GMP consulting for the
Import and Warehouse for Quarantine Storage
Import of Medicinal Products and Clinical Supplies from non-EU Countries Import of medicinal products and clinical supplies, based on §72 AMG (German Drug Law) Costom
Special service and technology
Purification of unknown impurities by preparative HPLC Manufacturing of emulsions and suspensions by High Pressure Homogenization Stability testing and storage of medicinal products in climatic
Expiriences and references
Experience / Register of drug substances Galenic and/or analytical developed products containing the following active substances Allopurinole DTPA MDP Pumpkin seed essence /oil Anastrozole
Cooperations
Regulatory Affairs Brinker-Pharmaconsulting, Dr. Annette Brinker www.brinkerpharma.de Clinical Studies SocraTec R&D GmbH; Prof. Dr Henning Blume & Dr Barbara Schug www.socratec-pharma.de Preclincal Investigations Veterinärmedizinische Fakultät
Management
Contact persons
Dr. Christian Brätter
Mr. Rudy Thoma