Drug registration of listed drugs that change dosage forms, change routes of administration and add new indications shall be declared in accordance with the new drug application procedures.
Therefore, it is necessary to have sufficient and reliable research data to prove the safety, effectiveness and quality controllability of drugs.
Drugs are not so easy to produce.
But it should be possible to apply for a patent, and the method can also be patented, but I don't know if it will be produced after the patent application comes out.