NanoViricides Inc. (NNVC)

[loanranger]

"The 'certification' of the new plant actually happens after they start producing."

I think that you are correct in putting the word "certification" in quotes. Apparently the process is referred to by the FDA as "Drug Establishment Registration".

http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm238034.htm
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf
1. Who must register, when, and how?
The owner or operator of an establishment entering into the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs14 and not exempt under section 510(g) of the Act or subpart B of 21 CFR part 207, must register the establishment with FDA within 5 days after beginning the operation (21 CFR 207.21(a) and 21 CFR 207.3(a)(8)). Alternatively, if the establishment has not previously entered into such an operation, the owner or operator must register within 5 days after submitting (among other things) a drug application, biological license application, or medicated feed mill license application. (21 CFR 207.21(a)).

Then, apparently at their leisure and not according to any predetermined schedule or time limit, the FDA pops by and assures itself that the company is complying with CGMP.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm

I'm not sure that there is actually anything formally known as a "Plant Certification".




ps. Don't rely on the accuracy of any of the above.