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Alhydrogel® Certifications

GMP-Certified Production Plant:

Brenntag Biosector is GMP certified by the Danish Medicines Agency according to §39, and thereby allowed to produce active pharmaceutical ingredients (API’s) for both human and veterinary use.

Additional Certifications:

A) FDA
Alhydrogel® 1.3% is covered by the FDA masterfile : DMF 2143
Alhydrogel® ”85” 2% is covered by the FDA masterfile : DMF 9822
Alhydrogel® 2.0% is covered by the FDA masterfile : DMF 2143

B) Canadian Health Agency
Alhydrogel® is covered by DMF 2001-084

Note regarding Drug Master File:

While customer access to Brenntag Biosector’s product master files are not granted (not even against a Confidentiality Agreement) a customer may need a Letter of Authorization from Brenntag Biosector for cross-referencing to the master file in question. The Letter of Authorization is then enclosed e.g. the IND by the customer to the local health authorities. This document enables the Health Authorities to get access to all the information in the masterfile, but in such a way so that the customers themselves are not granted access to the information.

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