Unichem's US plans take shape
pharmaceutical ingredients (APIs) and finished pharmaceuticals in
the country, has entered into an alliance that could see it
supplying generics into the US market.
The Indian company has signed an agreement with Lannett of the US for the exclusive supply of one or more APIs for use in generic drug products. Under the terms of the deal, Unichem will develop a formulation of the finished dosage product using its internally-manufactured API.
The move represents an acceleration of Unichem's International Formulations division activities in the US, the world's largest market for pharmaceuticals. To date the business has been represented mainly in the European, Asian and South American markets, and Unichem's activities in the US have been restricted largely to the supply of bulk APIs to customers.
The company has a foothold in Europe through the UK-based Niche Generics, in which it holds 60 per cent equity, and has filed 12 drug master files (DMFs) in Europe, alongside DMFs for bulk ingredients. In the US it is preparing to file abbreviated new drug applications (ANDAs) for generics in the US by 2004-05, with about three ANDAs being slated for the forthcoming fiscal year.
Lannett and Unichem will share the cost of bioequivalence studies for the generic finished product and the two companies will work together in preparing and submitting an ANDA to the US Food and Drug Administration for marketing approval.
A formulation development facility at Goa in India has been set up exclusively to supply the US market.
Once approved, Lannett will market and distribute the product exclusively in the US, and the profits earned on sales of the drug will then be shared by the two companies.
