Temmler Pharma - Contract Manufacture, Contract Development and Regulatory Services

Temmler Pharma GmbH & Co. KG, an independent pharmaceutical company, based in Marburg, Germany, offers full service contract manufacture, contract development and regulatory services for all solid oral and some liquid dosage forms and specialises in controlled release formulations. The company works according to EU and US GMP standards and has been inspected by the FDA several times.

Our full range of services covers galenical development, analytical development and validation, formulation optimisation, batch scaling up, pharma process validation, purchasing and testing of all starting materials, bulk manufacturing, primary and secondary packaging, quality control, ICH stability testing, supply of clinical trial medication, coordination of bio studies and regulatory services.

FULL SERVICE

Temmler's full service covers the whole range of activities from the purchasing and testing of all starting materials to the point of release to the market of the finished product. The company offers the straightforward production of generics and is also quite prepared to work on individual, tailor-made solutions and complex development and manufacturing challenges.

GALENICAL DEVELOPMENT

Temmler is experienced in the development of all solid oral dosage forms and some liquid oral dosage forms, with a main focus on controlled release formulations (sustained release, modified release, prolonged release) and organic granulation.

ANALYTICAL DEVELOPMENT AND VALIDATION

Development activities include the development and validation of analytical methods with special know-how in dissolution testing and HPLC testing.

FORMULATION OPTIMISATION

Temmler's galenical department optimizes formulations according to customers' requirements.

BATCH SCALING UP

Lab batches and pilot batches can be scaled up to manufacturing scale by Temmler.

PHARMA PROCESS VALIDATION

Temmler performs the process validation for all products manufactured at its site.

PURCHASING AND TESTING OF ALL STARTING MATERIALS

The purchasing and testing of all starting materials (APIs, excipients, primary and secondary packaging material) is an integrated part of Temmler's full service.

BULK MANUFACTURING

Temmler offers bulk manufacturing of the following solid oral dosage forms:

• Controlled release pellets and capsules
• Immediate release capsules
• Controlled release tablets
• Tablets (film-coated tablets, chewable tablets, dispersible tablets, effervescent tablets, sugar-coated tablets)
• Powders
• Granules

Specialist know-how is available in the fields of retardation of capsules and tablets (controlled release, sustained release, modified release, e.g. enteric coating), organic granulation (organic solvents: Ethanol, Isopropanol and Acetone) and encapsulation of pellets and powders. Liquid dosage forms can be produced as oral and topical solutions.

PRIMARY AND SECONDARY PACKAGING

Temmler's full service includes packaging into push-through packs (blister packaging in Alu/PP/PVC/PVDC), Alu/Alu cold form packs, bulk containers, tubes (Alu and PP) with desiccant stoppers, sachets, bottles, folding boxes with bar code printing and labelling (sequential bar codes).

QUALITY CONTROL

Temmler's quality control performs the testing and the release of the starting materials, IPCs, the final control of the finished products and their release.

ICH STABILITY TESTING

The generation of stability data in accordance with the ICH guidelines (storage and testing) is included in the range of services offered by Temmler.

SUPPLY OF CLINICAL TRIAL MEDICATION

Samples for clinical studies can be manufactured and supplied for development projects.

COORDINATION OF BIO STUDIES

Within the scope of development projects, Temmler also offers the coordination of bioavailability / bioequivalence studies.

REGULATORY SERVICES

Temmler's Drug Regulatory Affairs department supports development projects by compiling CTD dossiers and handling filings.