Query: I have planned to start a sanitizer business. But as I researched about it, I was told that I might need an FDA license to manufacture it. As I am just beginning, I have less capital.
I recently came across your article regarding “Manufactured by ABC and marketed by DEF”. It finally gave me hope to start my own small-scale business. But still I have some doubts. I would be grateful if you could help.
1. Do I need any kind of license if I want to use the “Manufactured by ABC and marketed by DEF” approach?
2. My plan is to get 100% pure Isopropyl/ethyl alcohol and dilute it to 75% myself with other raw materials bought from different manufacturers and then bottle it up. Will it still come under “Manufactured by ABC and marketed by DEF” approach or I will need a license.
3. I can’t afford an FDA license as it requires a large industrial area and huge capital investment with certified workers. Usually FDA license is required when you manufacture raw materials yourself but I would just dilute alcohol content. Would it still require license?
Response:
To understand your query, you need to fully understand the “Manufactured by ABC and marketed by DEF” approach. In Manufactured by and marketed by approach, manufacturers provide ready to sell products. They don’t provide partially mixed or unpacked material as you are planning to get 100% pure Isopropyl alcohol and dilute it to 75%. You will get ready to sell packed sanitizer and you only need to market and sell it.
1. You need a wholesale drug license for sanitizer manufactured under a pharmaceutical manufacturing license. No license will be required for selling sanitizer manufactured under cosmetic manufacturing license and ayurvedic manufacturing license.
2. This does not come under the “Manufactured by ABC and marketed by DEF” approach. It comes under the manufacturing process and you will require a manufacturing license from FDA for it.
3. FDA license is required for all manufacturing processes, not only for manufacturing of raw materials. Dilution comes under the manufacturing process. Not only license from FDA, you will also require to take excise license for procuring alcohol content from distilleries.
PS: “Manufactured by ABC and marketed by DEF” approach comes under third party manufacturing/Contract manufacturing. You send your requirements to manufacturer and manufacturer prepare the product with your brand name and marketed by address based upon requirements. You get a packed finished product.
Get 100% pure Isopropyl alcohol and dilute it to 75% is come under manufacturing and you have to complete all requirements and take sanitizer manufacturing license for it.