What is the cost of putting a new drug (not innovative) on the market?

[philly]

Thank you ever so much. It is a really valuable piece of information. I was intrigued by reading that my company would need a manufacturing licence. What is the whole idea of contract manufacturing based on then? Could you also reveal the cost of manufacturing/packaging a batch of 100,000 simple gelatine capsules? As far as I know, capsules are generally cheaper to manufacture than tablets.

[johnep]

Ask R P Scherer.
johnep

[Robert]

Thank you ever so much. It is a really valuable piece of information. I was intrigued by reading that my company would need a manufacturing licence. What is the whole idea of contract manufacturing based on then? Could you also reveal the cost of manufacturing/packaging a batch of 100,000 simple gelatine capsules? As far as I know, capsules are generally cheaper to manufacture than tablets.

There is no set price for the manufacture of 100,000 gelatine capsules. What size capsules? Do you mean empty capsules (probably not) or do you want them filled? Are you willing to share a batch? For example, say a large pharmaceutical company is ordering 10,5 batches of loperamide are you willing to take 0,5 batch so that the contract manufacturer can make 11 batches (if so, it'll be cheaper)? Etc, etc. You can be sure that the major part of the price is not the capsule, but the filling with drug product of the capsule.

I am not specifically involved in UK manufacturing/importer's licenses. So, please ask a QP in the UK to verify the specific UK details (I am in the Netherlands and things may be a little different here). Also, I am no longer involved in manufacture but only in regulatory affairs now. But anyway, here goes: Under GMP you as a contract giver are responsible for ensuring that the manufacture of your medicinal product is carried out in accordance with GMP rules. That means that you must assess the competence of the CM, that you give him all the information he needs to be compliant with the license and other legal requirements and that you are responsible for ensuring the quality of his materials, his processes, etc. In other words, you will need to certify that a given batch is manufactured in compliance with GMP. To certify a batch, which is a part of the manufacturing process, you generally need a manufacturers license.

In the Netherlands, the only way (currently, this is about to change) to do this is to make sure you have a license for giving the contract. It is also illegal to import any medicinal product from abroad to the Netherlands without such a license and I expect it to be illegal in the UK as well.
Since you are likely to procure you medicinal product to anyone other than the end-user, you probably also need a wholesalers license. Again, check with a local QP for details.