DFE Pharma Inhalation Product Development for the Pharmaceutical Industry

DFE offers high-performance solutions for the development of dry powder inhalation treatments.

As a leader in the field of inhalation, we collaborate with pulmonary delivery treatment developers and provide standard and customisable inhalation lactose grades.

Our expertise, as well as our three dedicated inhalation product sites, provides a unique starting point for any advanced pharmaceutical application.

Inhalation grade lactose for pharmaceutical applications

A growing number of diseases are being treated with inhaled medicines. Several treatments now utilise dry powder inhalers, which require a high-quality inhalation grade of lactose to control the formulation.

As every dry powder inhaler device is unique, each requires a particular grade of lactose to guarantee accurate product performance, predominantly for highly regulated markets.

Due to regulatory demands, all our inhalation grade lactose is manufactured in dedicated inhalation production sites.

Quality and regulation support

All production sites for inhalation lactose operate under Good Manufacturing Practice (GMP) standards, meeting the high-quality standards demanded by the US Food and Drug Administration (FDA) and other regulatory bodies.

A Drug Master File (DMF) is available to assist registration of a new formulation in the US. DFE Pharma also has several Chinese DMFs in place to support certification of dry powder inhalation products within the country. For optimal control on functionality and to comply with regulatory requirements, additional testing above the current pharmacopoeia is in place.

Technical support

DFE Pharma inhalation team develops pharmaceutical lactose that facilitates delivery of the active component to the lung.

We work closely with pharmaceutical companies to design lactose particles with the compulsory functionality for the treatment, unit and its filling platform. In addition, local technical support is available in various global regions.

Research and development capabilities

Through our research and close co-operation with research institutes and universities, we are continuously expanding our knowledge of lactose and other excipients for use in inhaled delivery.

The company focuses on the physicochemical behaviour of lactose under conditions relevant for use as an excipient in advanced pharmaceutical applications. With this knowledge, we can advise our customers on the latest scientific developments, as well as offer Lactohale® and Respitose® lactose brands.

Production capabilities

At DFE Pharma, we have three production sites committed to the manufacture of inhalation grade lactose each with unique capabilities:

  • Veghel (Netherlands) for the manufacture of Respitose products
  • Borculo (Netherlands) for Lactohale products
  • Kapuni (New Zealand) for the manufacture of Lactohale and customised inhalation products

We are the only excipient supplier with three production sites on two different continents for inhalation-grade lactose to ensure local supply. All three sites have been established to manufacture consistent and high-quality inhalation grade lactose to meet client expectations.

About DFE Pharma

DFA Pharma is recognised as a partner to the pharmaceutical industry, aiding individuals worldwide in leading healthier lives. We have spent more than a century providing a long-term commitment to our clients, as well as the millions of patients who use our products daily.

We are respected by our clients for product quality, practical market support and technical expertise, always working with the future in mind.

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Press Release

DFE to Exhibit at Online Event DPI China on 10 July

DFE is pleased to announce it will be speaking next month at DPI China as part of a special online conference,

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Your Inhalation Grade Lactose

As a leader in the field of Inhalation, DFE pharma offers pharmaceutical industry the most optimal solution for the development of their Dry Powder Inhalation drug.

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DFE Pharma

Klever Strasse 187

PO Box 20 21 20

47568 Goch

Germany

+31 6 5398 2549 +49 2923 9288 7799 www.dfepharma.com

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Press Release

6 July 2020

DFE is pleased to announce it will be speaking next month at DPI China as part of a special online conference,

Read more
30 June 2020

An innovative portfolio of excipients is being launched by DFE Pharma aiding in stabilisation of biologics, including samples of Trehalose and Sucrose (the first in this BioHale® range), available now for online purchase.

Read more

Regional Offices

DFE Pharma

Klever Strasse 187

PO Box 20 21 20

47568 Goch

Germany

+31 6 5398 2549 +49 2923 9288 7799 www.dfepharma.com
DFE India Office

Plot No 148

Prestige Featherlite Tech Park

2nd Phase, EPIP Zone

Whitefield, Bangalore 560066

India

+91 80 4925 6100 +91 80 4925 6150
DFE Singapore Office

3 Temasek Avenue

#11-01 Centennial Tower

Singapore, 039190

+65 6580 8100 +65 6580 8191
DFE Japan Office

Taiyo Seimei Bldg. 14F

2-16-2, Konan, Minato-ku, Tokyo

108-0075

Japan

+81 3 6260 0740 +81 3 6260 0754
DFE North America Office

61 South Paramus Road

Suite 535

Paramus, NJ 07652

United States of America

+1 551 497 7355 +1 551 497 7358
DFE China Office

Room 302

No 68 Bohang Road

Pudong Shanghai

China

+86 21 6134 5821 +86 21 6134 5800
DFE Brazil Office

Rua Fradique Coutinho, 30 - sala 61

05416-000 São Paulo SP

Brazil

+55 11 2395 1700
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