We take pride in servicing you to the best of our abilities within the shortest lead times. Helping you to pave the way with authorities is just one example. With our provided services we aim to speed up and facilitate your process with the authorities.
Drug Master Files
In order to facilitate the registration process for customer products or to support other Drug Master Files (DMF), Datwyler maintains following DMFs with the relevant Health Authorities. These DMFs cover Datwyler’s global operations.
US-FDA Type-III DMF
The Drug Master File (DMF) contains proprietary information on all standard compounds (both coated and un-coated) and on processes, particularly washing processes. All the records in the DMF are structured in the eCTD format (electronic Common Technical Document).
Health Canada Type-II MF
The Master File (MF) contains proprietary information on all standard compounds (both coated and un-coated) and on processes, particularly washing processes. All the records in the MF are structured in the eCTD format (electronic Common Technical Document).
NMPA, China DMF
According to the requirements of the current bundled review policy of China’s NMPA (National Medical Products Administration), Datwyler made a series of submissions for product type / compound combinations. Each submission has its own specific number, called registration number. The said submissions after administrative / technical reviews are published at the CDE (Centre for Drug Evaluation) platform.
Letter of Authorization
Submission of drug applications.
To facilitate the submissions of drug applications or to support other DMFs, Datwyler can provide Letters of Authorization (LOA), free of charge.
To request a Letter of Authorization, please fill out the following LOA Request Form (PDF) and send it back to us by email.
More information about the purpose and contents of FDA Drug Master Files can be found on the FDA website. Guideline about Health Canada Master Files can be found on Health Canada website.