Theon Pharmaceuticals is a manufacturing concern which does not sell its products directly in the market. It manufactures products for third parties like Abott, Cipla, etc., and is therefore only involved in Business to Business sales in the domestic market. Since the company is doing well with its existing client base with timely deliveries and ever-increasing revenues (as mentioned in the case), it clearly indicates that its business model is doing just fine. The only improvement that it requires is in terms of value addition which can be gained by company’s expansion either by enhancing its production capacity, adding to its product line or increasing exports. With its already sound reputation, Theon Pharmaceuticals should consider a shift…show more content… They had to do quality check and proper packing (palletization or crating) of the products to be exported.
Every time they exported a pharma product, they had to obtain Certificate from Wildlife Protection Board and NOC from Drug Controller. Presently Theon Pharmaceuticals are able to export only to Semi-Regulated countries. Theon Pharmaceuticals depend upon Third party logistics provider for their export consignments.
Regulated and Semi-Regulated refers to the spectrum of control a govt institutes in the pharmaceutical industry, from requiring papers of R&D depts., reviewing results of clinical drug trials, and controlling the environment in which a drug is manufactured through tough licensing laws.
Drug regulatory affairs in pharma industries has mandated two types of dossier namely CTD (Common Technical Dossier) and ACTD (Asian Common Technical Dossier ).
Regulated pharma markets (e.g. USA, Europe, Japan) markets require submission of dossier in CTD format which has to provide clinical trial and bioequivalence