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Re: Its_lose_not_loose post# 129856

Wednesday, 02/15/2017 5:40:45 AM

Wednesday, February 15, 2017 5:40:45 AM

Post# of 146291
"A minimum of two consecutive reproducible batches are generally required to be made before qualifying a product, process, and facility under c-GMP. In addition, we will also need to seek and obtain US FDA registration as a cGMP facility, after we successfully commission c- GMP-like production of at least one drug substance at this facility. "

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