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Cambrex Profarmaco Milano S.r.l.

PRODUCT TYPE OF CHANGE ASMF EDITION

EMTRICITABINE NEW SUBMISSION Ed 01.00/2012-ASMF (October 2012)

PARAGRAPH

DESCRIPTION

MODULE 1 MODULE 2 MODULE 3 - SECTION A (3.2.S.1)

Information about the expert / Environmental risk assessment Quality overall summary (QOS) Quality Drug substance General information Manufacture Characterization Control of drug substance Reference standard Container closure system Stability

- SECTION B1/2 (3.2.S.2) - SECTION C - SECTION D - SECTION E - SECTION F - SECTION G (3.2.S.3) (3.2.S.4) (3.2.S.5) (3.2.S.6) (3.2.S.7)

This is the first edition of the Active Substance Master File (ASMF) Ed.01.00 for Emtricitabine. This dossier was prepared according to the CTD-format, described in the NTA, Vol.2B.

Emtricitabine, Ed 01.00/2012-ASMF

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