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Drug Master Files (DMF)

How to register your pharmaceutical containment solution in China, the USA, and Canada

Drug Master File registration

To register your pharmaceutical containment solutions in China, the USA, and Canada, SCHOTT Poonawalla will support you in the preparation and registration of their Drug Master Files (DMF). These essential documents describe the difference between the pharmaceutical containment solution and the final drug.

During a review by the relevant authorities, the Letter of Authorization (LoA) will contain SCHOTT Poonawalla’s contribution to the DMF. The content provided by SCHOTT Poonawalla for the DMF and LoA can be used for a number of drug applications using the same pharmaceutical containment solution.
Drug Master Files for quick and smooth referencing
We have a highly experienced Regulatory Affairs and Compliance Team that generate, file, and update DMFs. This allows our customers to use SCHOTT Poonawalla’s containment and delivery solutions as either pharmaceutical packaging or medical devices, using the latest authority guidelines to offer a rapid and reliable review of your drug application.

For applications in China, we generate and update bilingual DMFs in the appropriate dossier format, and for the USA and Canada, DMFs are created and maintained as Electronic Common Technical Documents (eCTD).
SCHOTT Regulatory Services - Drug Master File

The complete Drug Master File

DMFs generated for SCHOTT Poonawalla’s range of drug containment solutions describe the complete system and its components. Therefore, a single DMF will include the entire containment system rather than a variety of links with content for each component.
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Complete coverage – Includes documentation for all packaging system components, including elastomers

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Simple online request – Rapid delivery of your Letter of Authorisation (LoA) within three weeks

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Document updates – Maintenance of the DMF in eCTD format to enable up-to-date validity and version control

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Direct authority contact – Ensures rapid response to urgent issues

Get in touch

Mahesh Italiya

Mahesh Italiya

Quality Head

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