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Hisun’s Taizhou plant is still under an Import Alert. However, on 18th February this year, FDA revised its ban against Hisun’s plant in Taizhou issued in September last year.
The cost of the raw materials varies in proportion to the production amount of the product, and this is called variable costs or proportional costs. On the other hand, equipment cost and labor cost of operator are irrelevant with the production amount and kept fixed, and they are called fixed costs. Next, let us discuss how much fixed costs and variable costs will be spent to produce drug substance in standard plants using standard personnel.
I would like to introduce the knowledge and know-how of drug substance manufacture I have gained from long time work on drug substance process research and production without breaking any confidentiality. I hope this article will help readers engaged in pharmaceutical manufacture to make deeper understanding of drug substance production.