Tuesday, 21 May 2019

Haselmeier acquires drug manufacturing license

15 February 2019 | News

Haselmeier will in future assemble the cartridges supplied by customers for the respective therapies with the injection pens as well as label and package the combination products.

As an innovative and strategic partner for pharmaceutical and biotechnology companies, Haselmeier develops and produces customized, unique self-injection systems that are used worldwide. The quality, reliability and ease of use of these high-tech products play a key role in the therapeutic efficiency and quality of life of patients.

Haselmeier has been in possession of an allowance to manufacture pharmaceuticals since December 2018, which is done at the production site in Buchen, Odenwald, in accordance with §13 of the Medicines Act (Arzneimittelgesetz - AMG) or according to Art. 40 of Directive 2001/83/EC. Haselmeier can now offer pharmaceutical and biotechnological companies an assembly, labelling and packaging service.

Konrad Betzler, Chief Quality Officer of Haselmeier: "I am pleased that, after extensive preparatory work and in close coordination with the responsible GMP supervisory authority, we have now received the manufacturing permit".

Haselmeier will in future assemble the cartridges supplied by customers for the respective therapies with the injection pens as well as label and package the combination products. This service also includes the manufacture of batches for stability testing. Haselmeier thus offers important complete solutions, for example for pharmaceutical companies in the production of small and medium-sized series for clinical studies as well as for biotech start-ups.

Haselmeier is a leading developer and manufacturer of innovative self-injection devices that feature company designs and state-of-the-art technology. Haselmeier has more than four decades of experience in the field of medical devices. Through the years, the company has built up a top-class planning and development team that is responsible for the design, planning and industrialization of our innovative self-injection systems - and thus manufactures successful products that are used by pharmaceutical and biotechnology companies worldwide.

Haselmeier with headquarters in Switzerland, employs around 200 people worldwide. The company has sales offices in Europe, the United States and India. The Haselmeier-products are manufactured in state-of-the-art production facilities in Buchen, Odenwald (Germany), Dnešice (Czech Republic) and Bengaluru (India).

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