Generics Pharmaceutical Manufacturer Questions

Posted on: October 15, 2018 by in Blog
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Hi everyone,

I need some help. I really would like to start a generic pharmaceutical company and I am not sure where to turn after searching extensively online. I know about the products and distribution (which products are selling the most on IMS and Symphony in which formulation and dosage, pricing consortium issues, WACs versus rebates), general ANDA and 502(b)2 processes (paragraphs 1, 2, 3, FDA wait times, requisites for bioequivalence) but I really need help understanding the required initial starting points. I have written some questions down below; if anyone is working at a specialty or large capitalization pharmaceutical company and could help me out, I would be delighted.

No joking: sometimes friendships and the start of terrific opportunities can stem from simple online interactions. Chemists are smart people and this is a terrific forum filled with smart people, please definitely send me a message if you are interested in the business-side of pharmaceuticals and know something about the chemical aspects. I would be glad to have a conversation.

Questions:

  1. Exactly which parts of the manufacturing process does the FDA need to approve relating to plants? I know that the FDA needs to approve specific API suppliers (often in India or China), but how does this process take place and how difficult is it to get an FDA plant approval in the United States? Is it the manufacturing aspect only, or what about packaging and pre-production of generics (mixing raw API and other ingredients)?
  2. For early generics companies that do not have their own manufacturing facilities (which is usually the case until they are able to build a plant), where do the founders conduct their initial bioequivalence tests and eventually produce their first generics for distribution? Do early founders use the finish/fill facilities of other manufacturers? How is this relationship from a pricing perspective (is it fair or is this really hard at first)?
  3. Is there a good place that pharmaceutical chemists frequent (forums, websites, conferences, or similar place)? I would like to hire a quality chemist cofounder but it is very hard in my experience to find someone who knows how to chemically produce the molecules and run the bioequivalence testing.
  4. Has anyone gotten a generic drug approved with the FDA that could share their experience? Which parts were easy? Which parts were hard? How did you choose where your generic was manufactured? Which ANDA paragraph did you follow? What was the sales relationship with a consortium or commercialization partner once the generic was approved and how did you feel about pricing (once you got approval and had your manufacturing in place, how was the sales relationship with your customer/wholesaler/PBM/consortium)?

Thanks for your help! Please only answer what is comfortable to talk about.

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