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Drug Master Files (DMF)

Pharma containment solution registration in the USA, Canada and China
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Drug Master File registration

For drug registrations in the USA, Canada, and China, SCHOTT Pharma prepares descriptions of pharmaceutical packaging products and registers them in Drug Master Files (DMF). These files separate the descriptions of the pharmaceutical packaging or medical device from the descriptions of the final drug or medical device.

The content that SCHOTT Pharma contributes to the DMF is referenced via a Letter of Authorization (LoA). During authority review, the LoA is considered part of your drug application. You can use the DMF and LoA references provided by SCHOTT Pharma for the same pharmaceutical packaging across multiple drug applications.

Drug Master Files from SCHOTT Pharma for fast and seamless referencing

Our Regulatory Affairs and Compliance Team takes care of generating, filing, and updating DMFs. In the USA and Canada, DMF filings are generated and maintained in eCTD format, while in China we create and maintain bilingual DMFs in a China-specific dossier format.

Our DMF setup enables customers to use SCHOTT Pharma containment and delivery solutions as pharmaceutical packaging or medical devices. In format and content, our DMFs follow the latest authority guidelines to promote a fast and seamless review of your drug application.

World map with the USA, Canada, and China highlighted in blue

SCHOTT Pharma’s DMF’s: a single, complete dossier

DMFs for SCHOTT Pharma containment and delivery solutions, such as prefillable syringes and cartridges, describe the complete system and its related components. As a result, the entire containment system can be incorporated into the drug and medical device submission via a single DMF, as opposed to creating multiple links with separate content for each component.
CHECK REGULATORY AVAILABILITY

Full coverage - Contains documentation for all components of the packaging system, including elastomers.

Easy online request - Ensure fast delivery of your Letter of Authorisation (LoA) within three weeks.

Document maintenance - Ensure maintainance in eCTD format with validity and version control.

Direct contact - We will get in touch with Regulatory Authorities for a fast response to urgent open issues.

Check regulatory availability

If you are planning to register your drug or medical device product and would like to check current availability, SCHOTT Pharma can provide a summary of the regulatory availability specific to your product and countries of interest.

Drug Master File by SCHOTT Pharma

Drug Master Files: How to proceed

In the USA and Canada, DMFs are available for our platform products to ensure smooth regulatory approval. Additional registrations may be required for customized products or registrations in China.

If urgent authority responses are required, please use the contact form or inform your sales contact to establish direct support via our regulatory experts.

1. Get in touch

Please tell us about your products and the countries you wish to focus on by using the online form for regulatory availability check.

2. Receive a status report

This report lists all currently available DMFs and other registrations, as well as coverage of your product combination and how to proceed in the event of incomplete coverage.

3. Initiate DMF updates

If required, our regulatory expert team will take care of extending established DMFs or registering new DMFs to cover your product.

4. Updated status report

Lastly, you will receive an updated status report informing you of the established registration state of your products and countries of interest.

Get in touch

Dr. Frank Hoffmann-Geim

Dr. Frank Hoffmann-Geim

Director Regulatory Affairs

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