In December 2003, Spectrum announced a marketing and supply agreement under which FDC will develop and manufacture generic drug products in India, and Spectrum will pursue the regulatory approval, marketing and distribution of the approved drugs for sale in the United States.
FDC manufactures ophthalmic and otic drugs in unit and multi-dose packages as well as select active bulk ingredients (API's) at a U.S. FDA approved plant in Roha, India. The bulk drugs manufactured at this plant are either exported (more than 80% of the production) or formulated into finished drug products at the Company's plants in Mumbai, Goa, Nasik and Aurangabad. The Company's modern plant in Goa commenced commercial production in September 2000, and was designed to meet MHRA/EU GMP/FDA standards. The Company is also setting up a second manufacturing plant at a separate site in Goa, which will provide additional capabilities with quality systems meeting the highest International (ISO) GMP Standards. Scale-up runs and commercial production are expected to commence in March 2004.
Prescription sales for eye care pharmaceuticals in the U.S. exceed $2 billion and continue to grow with the aging population.
Under the terms of the agreement, Spectrum has exclusive rights to market and distribute products, mutually agreed upon by both parties, in the United States. Initially, the agreement calls for ophthalmic products with plans for expanding the list. FDC will manufacture and conduct the necessary tests for approval of the products, and Spectrum will be responsible for all regulatory, marketing and distribution matters in the United States.
FDC Limited – Website
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