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P. 10-13 /

Conflicts and opportunities in the Life of APIs

corresponding

GIRISH MALHOTRAEPCOT
International, 29150 Bryce Road, Pepper Pike, OH 44124, USA

Abstract

Consumers would like to have drugs that are of consistent quality and at the lowest price. However, with Pharma’s current business model considerable effort is needed to maintain product quality and there are conflicts. Focus of the current pharma business model is invent a new molecule, commercialize and abandon i.e. let the generics take over when the patent expires. Due to less than efficient manufacturing technologies considerable effort is needed to maintain quality and comply with regulatory requirements. Even with this effort companies come short as evident by recent recalls and consent decrees.
Making a grass root change in process development and manufacturing practices can easily eliminate these conflicts. One has to understand and exploit physical and chemical behavior of chemicals (sociochemicology) of the chemicals involved and produced in the manufacture of active ingredients. Creative application of unit processes and operations is equally important. Such processes not will produce quality product but will have lower manufacturing cost (higher profit), will be safe and sustainable.


Consumers would like to have drugs that are of consistent quality and at the lowest price. However, with Pharma's current business model considerable effort is needed to maintain product quality. It is a continuous challenge as seen from numerous recalls and citations. Drugs are priced at the highest-level customer can afford. Rationale is our sentiment that we want to extend our life at any cost. Competitive pricing is generally not a consideration. This is very unlike any other competitive business. Many governments are making every effort to control drug prices. It is a battle.

During and after patent life of every API and its formulation conflicts come in the way of the lack of best manufacturing technologies and lowest costs. A review of the business models might explain why the conflicts exist. Focus of this article is to discuss how we can have the best technologies that deliver highest quality API (small molecule) and their formulations at the lowest cost. Methods that can improve the manufacturing technologies are also briefly reviewed.

CURRENT BUSINESS MODEL AND MANUFACTURING PRACTICES

Brand/ethical pharma
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