Australian Public Assessment Report for Trastuzumab
The GMP follow-up inspection of the proposed drug product manufacturing site at Biocon Ltd (Bangalore, India) in March 2018 resulted in GMP compliance. On 10 Sep 2018, the sponsor provided the TGA with the Rapporteurs’ Day 150 Joint CHMP and PRAC response assessment report, dated 28 August 2018, which recommended approval. ................
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