Regulatory Support

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.

USA

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).

Canada

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).

China

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.