DFE Pharma celebrates the 20th anniversary of its production site of lactose-based excipients in Nörten-Hardenberg

Norten Hardenberg

DFE Pharma, a global leader in pharma- and nutraceutical excipient solutions, has celebrated the 20th anniversary of its production site at Nörten-Hardenberg, Lower Saxony. At this plant, the company produces premium lactose-based excipients for use in oral solid dosage (OSD) forms, such as SuperTab® 11SD, SuperTab® 21AN and SuperTab® 30GR.

The Nörten-Hardenberg site is a key part of the global manufacturing network of DFE Pharma. “The roots of DFE Pharma date back to more than 100 years ago and the company started to produce pharmaceutical grade lactose excipients in the 1060’s. Since then, the company has become a global leading company in the industry with a wide range of products that comprise filler/binders for OSD, stabilizers for biopharma applications, as well as carriers and stabilizers for inhalation” explained Martti Hedman, CEO of DFE Pharma, “Together with starches, microcrystalline cellulose and disintegrants, lactose-based excipients are a key offering of DFE Pharma’s portfolio. Almost 1 out of 2 lactose including tablets globally use products of DFE Pharma. Our site in Nörten-Hardenberg plays a crucial role in supplying our customers from all over the world with premium lactose-based excipients to be used in advanced manufacturing processes”.

DFE Pharma’s manufacturing facilities at Nörten-Hardenberg were opened in 2003 with the completion of a Roller Dryer and a Spray Dryer to produce direct compressible lactose (DCL). Afterwards, the plant was also equipped with an Agglomerator, and in 2015 a major site upgrade project was started to add another roller dryer production line as well as other enhancements like utility upgrades (steam supply, water supply with clean water, cooling, pressurized air), waste water treatment (fully automated and controlled), IT systems improvement, etc. “The plant is being continuously invested in, which is reflected in the opening of its extension building and the commissioning of the fourth production line Roller Dryer 2 as the most recent milestones” said Gerhard Windecker, manager of Nörten-Hardenberg site.

This cutting-edge production site meets all Pharmaceutical Excipient GMP standards, securing a high level of manufacturing consistency required by the pharmaceutical industry to produce premium-quality excipients, as well as it is ISO 9001:2015 certified. DFE Pharma has also implemented a quality system in compliance with the Joint Good Manufacturing Practices Guide For Pharmaceutical Excipients (IPEC Federation).

All the excipients produced at this site comply with major pharmacopeia, that is the European (Ph. Eur.), Japanese (JP), Chinese (ChP), and the U.S. Pharmacopeias and National Formulary (USP-NF); as well as being Kosher & Halal certified.

DFE Pharma is also working on advancing its sustainability goals across all its sites, including Nörten-Hardenberg, which is already ISO 50.001 certified (energy management) and aims at certification of ISO14001 later this year (environmental management).

The anniversary event gathered together the Nörten-Hardenberg plant employees and their families with colleagues from other locations of DFE Pharma. The event was also attended by Ms. Susanne Glombitza, mayor of Nörten-Hardenberg and Ms. Astrid Klinkert-Kittel, county commissioner of Northeim.

Currently, the buildings at the site spread over 5000m², employing 70 people. "DFE Pharma is an important employer and partner for the area of Nörten-Hardenberg” highlighted Ms. Glombitza.

During the anniversary event, Ms. Klinkert-Kittel explained that “Various investments and innovations have contributed over the years to making the DFE Pharma site in the Northeim district an important part of the company's international presence. This is also a gain for our region. I am confident that the success story of DFE Pharma here in Nörten-Hardenberg will continue to unfold with many more chapters”.

Besides these facilities at Nörten-Hardenberg, the production network of DFE Pharma also includes other 4 manufacturing plants in the Netherlands, India and New Zealand, to secure a robust supply chain to serve its customers globally.