And that has tremendous advantage in that if there is a catastrophe on one site, you have business continuity where you have another site to continue your business. But it has the disadvantage of being very expensive to duplicate the equipment. And it also is very expensive to run clinical trials to transfer the extended-release products. So another option would be to do something similar, get another facility, retrofitted, but only transfer the IR products, instant release, because the instant release products do not require clinical trials, they just require that you manufacture the lot, place it on stability, so that it’s equivalent to where you manufacture somewhere else, file a CBE30 and transfer it. The process takes a few months, and it doesn’t cost much.
It’s all internal. But it still costs a lot of money to buy a plant, duplicate equipment and all of that. So for option one and option two, the cost estimate is between $25 million to $35 million. Option three was what we decided to do. So let me walk you through that since it is going to be a part of the company. Our current facility is about — the manufacturing facility is 36,000 square feet. But you are facing the facility on one side, you enter the APIs and IPIG, enter all the components from there, the trucks come in and that’s where you put them. The middle of the facility is where you do all of your manufacturing. And the right side of the facility is where you package and get the product out. So what I thought will be inexpensive for us to do and help release the company is, if we take the final part out where all the finished product which has to be in the vaults and the package, take that out and move it to a packaging facility and a storage facility that will give us enough space for expanding manufacturing for the future.
And now we have a new facility where we have two packaging lines instead of one, so we have unlimited capacity. We have a much larger vault and we have stories for the non-controlled substances. So that was the option we decided to go with, and we were lucky enough to find a facility within a mile from North Whale, which means our staff can actually — they don’t have to quit and will have somebody else to work in Philadelphia and Long Island, they are next door, so we can retain the current staff. They just moved next door and continue working for Elite. Managements gets to keep an eye on the staff. And the cost is only about 10th of starting a manufacturing facility, about $2.5 million. I am happy to report that I got the approval of the Board of Directors and signed the letter of intent on Monday.
We are in the middle of negotiating the details, and I expect that by mid next year, we will move into the new facility. So we have our products, we have our sales and marketing that’s selling the products and generating today’s revenues, we have set up the facility to be good to go for the next five years, at least. Now we need the pipeline in order to keep the business growing and in case if anything happened where somebody enters the market and our share gets reduced, that does not affect the company. In fact, we want to increase our share in sales and marketing by introducing other products, and that’s where R&D comes in. We will definitely continue to invest in product development. Our goal is to commercialize a new competitive products and diversify our portfolio.
Commercial product line is nothing but an R&D line that made it to the market. So I’m always thinking R&D is an extension to the market because that’s all it is. They are the commercial product today, they are the ones who are bringing the revenues and the R&D is the one that’s going to bring the revenues in the future. So investing all the profits we have into R&D is the right thing to do. So let me walk you through what happens when we file an ANDA, so I can update you on the ANDA as that are in the queue. After everything is done and we compile an ANDA, and you do the clinical trials and the recession, get to the point where you have filed with the FDA, you have to send it through FDA’s gateway. It’s an electronic means for them to receive it from you.
Once we do that, the FDA will look at all the sequences and say, okay, you got all the parts in here, so we acknowledge that we received it. Then they give themselves 45 days in order to look at the components of the ANDA and make sure that you covered everything that it’s linked properly, that all the parts of it that are critical are there. And ANDA have 5 parts, module 1 through 5. Module 2 is for the clinical trials. Module 5 is also for the clinical trials. Module 3 is for the chemistry manufacturing and controls, that’s where you have the drug substance and drug product. So they look at all these components and they say, fine, now it’s accepted for review. That’s when we will make an announcement that this ANDA has been accepted by FDA, and this will be the PDUFA date or at least the filing days, okay?
