Regulatory control of all ingredients used for inhaled medication is naturally strictly defined and enforced. That’s why all DFE Pharma inhalation are manufactured in dedicated inhalation lactose production locations that meet the high quality standards that are demanded by the FDA and other regulatory bodies. A Drug Master File is available to assist in the registration of a new formulation in the United States. We work closely with formulators to control drug functionality and ensure full regulatory compliance.
For optimal control on the functionality and to comply with regulatory requirements, additional testing above the current pharmacopoeia is in place.
DFE Pharma helps formulators to develop new treatments and take them to market faster than before. Our aim is to help our clients refine and improve the effectiveness of their medicines and reduce the time needed for approval and launch. Our pharmaceutical lactose facilitates delivery of your active ingredient to the lung.
The effectiveness of all inhalation drugs is linked directly to the inhalation lactose that delivers the active ingredient to the patient. We therefore work closely with pharmaceutical companies to design lactose particles with the required functionality or the drug, device and filling-platform. To enable a smooth development of a client’s product our specialist team can help advice and/or develop products from clinical through scale-up into production batches.
To find out how we can improve the quality and effectiveness of your products contact us now.