Glenmark, Shasun partner to develop and market generics in US

EPP News Bureau - Mumbai

Mumbai-based Glenmark Pharma Ltd and Shasun Chemicals and Drugs Ltd have entered into a collaboration agreement for the joint development, filling and marketing of twelve generic pharmaceutical products for the US market. The product list includes a mixture of off-patent and patent-protected molecules with cumulative annual sales of $8 billion in the US.

Under the agreement, Shasun will develop and license to Glenmark, 12 generic products. Glenmark in turn, will be responsible for filing the ANDAs and obtaining regulatory approval in the US market. Once the approval is received, Glenmark’s US subsidiary, Glenmark Pharmaceutical Inc will do the marketing, while Shasun will be responsible for manufacture and supply. All development and regulatory costs and profits on sale in the US will be shared equally between Glenmark and Shasun. Products under the agreement are expected to be filed over a three-year period with the first filing expected by 2005.

Glenn Saldanha, MD and CEO of Glenmark Pharmaceutical stated, “Apart from being a very successful API player, Shasun has invested in building excellent skills and infrastructure in the formulations business. We are very happy to partner with such a serious vertically integrated company. This relationship brings together the strengths of the two companies and accelerates our joint ability to become serious generic players in the US market.”

S Abhaya Kumar, joint managing director of Shasun Chemicals and Drugs Ltd stated, “Shasun has gone ahead with the forward integration by putting up the formulation plant at Pondicherry at an investment of Rs 40 crore with an idea to provide the ‘one stop shop’ in the pharmaceutical field for outsourcing by any pharmaceutical company. Shasun’s policy at present is to be the preferred outsourcing partner with the innovator as well as generic pharmaceutical companies to meet their needs of finished dosages by manufacturing and supplying the same.

This process would involve R&D steps of developing both processes of API as well as of formulation and then scaling up the processes so developed to commercial scales. We are happy to tie up in this regard with Glenmark who are now focused to be a leading player in the US market.”