Zydus enters US generics market

Gujarat-based pharmaceutical major Zydus Cadila Healthcare Ltd has made a foray into the US generics formulations business with the launch of Zydus Pharmaceuticals USA Inc.

Focusing on generics formulations business, the new company will supply finished dosage formulations to the US Generics market, the company said here on Thursday. Zydus Pharmaceuticals USA Inc will be headed by Joseph Renner as the chief executive officer of the company.

Renner was earlier the chief operating officer of Sandoz, USA, previously Geneva Pharmaceuticals.

In addition to the US initiative, the group has already started operations in Europe.

Zydus Cadila has a ready base in France with the recent acquisition of Alpharma France.

Company officials on Thursday said entries into the German, Spanish and Italian markets are in the offing.

As a first step in its plan to establish operations in the US pharmaceutical market, Zydus Cadila had earlier set up Zydus Healthcare LCC, a US-based company focusing on sales of active pharmaceutical ingredients (APIs).

This company was set up in 2002.

This development is in line with initiatives that the group has undertaken in the recent months to position itself as a global pharmaceuticals company.

Pankaj Patel, chairman and managing director of Zydus Cadila Healthcare, said, "Significant effort and progress has already been made to realise our plans to grow revenues from the overseas regulated markets. These efforts have been accelerated with the setting up of Zydus Pharmaceuticals USA Inc. We are now best placed to cater to the US generics market in terms of both API and generics formulations."

The company has already filed 12 API drug master files (DMFs) and two finished dosage drugs with the US Food and Drugs Administration.

It plans to file seven more drug master files s and six more finished dosage drugs with the US FDA by the end of the current fiscal.

The group has firmed its entry into the US, European and Brazilian markets with the formation of Zydus Healthcare (USA) LLC, Zydus France SAS and Zydus Healthcare Brasil Ltd, respectively.

The group has also emerged as the largest Indian group in formulation sales to Sri Lanka and is among the top five Indian companies in Myanmar, Uganda, Vietnam, Mauritius and Singapore.