dear all
does cyclosprine production need separate facility like antibiotics or can be produced in the main plant
It is a Immunosupressent and is a is a cyclic nonribosomal peptide. Its prepared by peptide sythesis. It has many adverse reactions. It should have a dedicated plant for manufacturing the bulk and also should have a dedicated line for formulating it.
I am rising this issue after a long time. Is there any guideline support this. Thanks in advance.
You should consult regulators in region where you register products and manufacture.
It also dependent up on under what class of this drug is classified under such guidelines.
If it is a clinical drug at that place it attracts other guidance.