The real question is can it be sold? And the answer is yes. Changes in the process are routinely handled as supplements to applications and you should look at the biologics regulations, CFR21 601.12. So if your PQ that required the API to be processed, you have successfully validated and you have a number of lots that have been manufactured as part of the conformance to your protocol, then yes, there isn’t any reason that those batches couldn’t be sold after approval of the supplement.
