No worries, here is what I posted awhile back as you can see what it takes to launch a drug and directly with regards to the methotrexate based on my experiences:
Good morning James, I had previously alluded to how long it takes for a launch in a previous email. Anticipate 2-4 weeks post approval for the API to come in and be released, then they need to schedule a total of 3 process validation commercial scale batches. There is a lot of paperwork associated with these. Anticipate another 4 weeks for this to be performed. Then all of the samples need to be tested and all of the validation reports signed off by QA so another 4 weeks. To be conservative once approval is given if they did not have everything in place, which most companies do not as you never know when FDA approval will come, I would anticipate about 3 months until official launch of a drug product. Based on my estimates I would anticipate launch of this one sometime middle to end of August. Once again this is conservative, and timelines can always shift or be sped up but this gives everyone an idea of time to launch. Cheers
Now Elite could actually launch these drugs faster but as Nasrat stated on the call, it would bog down the QC department. As I alluded to above you have to make 3 batches to launch a product and remember each strength of a product is a different batch and formulation. So this adds up quick, let's take APAP/Codeine coming next, 3 strengths would mean that they probably need to manufacture 9 batches. Thats a lot of samples to test and release as usually a finished product has at least 4-5 tests to perform to release the lot. Now also remember that the first 3 commercial batches have to go on long term shelf stability for 24-36 months with pull dates at 3,6,9,12,18, 24 and 36 months. So what Nasrat is doing is he is staggering the launches to be able to handle all of the testing in the lab. Nasrat and his team know what they are doing and so far they are doing an awesome job. And remember Nasrat stated that he had everything to launch the new CNS drug already. Now that little breadcrumb if it is accurate means approval is imminent and not November like everyone is thinking!!! Cheers everyone and this is getting fun to watch and playout like we had hoped. My dad and I will be joining for the Vegas trip as well.
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