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TÜV certification for the Bengaluru facility

Stuttgart, Germany, 7th December 2016

Haselmeier is pleased to announce that its newest production facility in Bengaluru (India) received its official certification from TÜV SÜD on 21st September 2016. Thus, the Indian plant is compliant with the necessary international requirements in all areas and demonstrates the high standards with which Haselmeier has achieved its excellent reputation in the industry.

The final measures to qualify the machines and systems at the Bengaluru facility were executed from January to late summer 2016. This also involved preparing the documentation needed for proper manufacturing of insulin pens, e.g. process descriptions and releases. The plant was audited by TÜV SÜD in July 2016, and the official TÜV certification document was received on 21st September 2016, confirming that our new facility in Bengaluru is compliant with international regulations and standards. TÜV SÜD Certificate No. Q2N 16 07 96203 005 relates to the “manufacturing of injection systems for self-injection and their components”. It includes applied standard EN ISO 13485:2012 + AC 2012 and describes the specific requirements for quality management systems in the medical products industry. Extensive staff recruitments to fill all the positions needed in a smooth-running factory accompanied these activities and procedural processes. The new colleagues were highly qualified for their particular fields of work.

Haselmeier is now in a position to supply the Asian market more easily and more effectively with medication dosage systems and, as a result, significantly improve life for patients. Our Plant Director, Indrajith Natarajan, explains: “Having Haselmeier built similar infrastructure to the existing German Facilities in Bengaluru – India, helps us to provide a quality focused atmosphere for our employees. This leads to the production of self-injection devices on the same quality level as the other Haselmeier facilities. The TÜV certification helps our customers to easily recognize our quality standards."

About Haselmeier

Haselmeier stands for the development and production of innovative self-injection devices with awardwinning designs. The Haselmeier Group primarily works on behalf of pharmaceutical and biotechnology companies to improve the lives of patients by manufacturing pens and auto-injectors that are easy to use and that can be dosed with precision. The family business covers all steps—from design to planning to industrialisation—in the creation of high-quality self-injection systems.

Founded as early as in 1920 in Stuttgart, Haselmeier has long been an established name in the medtech industry, thanks to its proprietary technologies and international award-winning designs. In four years from now, this well-established company shall be able to look back on a 100 year old success story. Spread across eight global locations on three different continents, the Haselmeier Group employs a workforce of about 220 employees. While the Development department is located in Stuttgart, Haselmeier products are manufactured in the most modern production facilities in Buchen in Odenwald (Germany), Dnešice (Czech Republic) and Bengaluru (India). The international sales are controlled from Stuttgart and have representations in Zurich (Switzerland), Lowell, Maryland (USA), Gurgaon (India) and Guangzhou (China).

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