DMF Letter of Authorization Request Form

We have submitted Drug Master Files (DMFs) to Japan and US Health Authorities to support our customer's regulatory activities. Thes Master Files can be cress-referenced through Letters auf Authorization (LOAs) in Marketing Authorizations, IND, BLA, NDA, ANDA or other DMF applications.

For US (FDA)
Please complete this form to request a Letter of Authorization for our Sartorius CellGenix Drug Master Files. Please bear in mind that our DMFs are submitted to the US FDA CBER center.

For Japan (PMDA)
Contact our Regulatory Support Team by e-mail to request a Letter of Authorization to cross-reference our CellGenix® GMP SCGM DMF. Please provide your company name, name of the contact person and name of the drug Marketing Authorization. You do not have to fill out the below form.

Sartorius CellGenix Product

Authorized Party
(i.e. company or individual who submits an application to the FDA - adresses of the LOA

(to whom change notifications should be addressed, as required by 21CFR 314.420(c))

Application Information