Spectrum and FDC in marketing and supply agreement
US-based Spectrum Pharmaceuticals has signed a marketing and supply agreement with Indian generics manufacturer FDC, of Mumbai, under which FDC will develop and manufacture generic eye-care drug products in India, and Spectrum will pursue the regulatory approval, marketing and distribution of the approved drugs for sale in the US.
US-based Spectrum Pharmaceuticals has signed a marketing and supply agreement with Indian generics manufacturer FDC, of Mumbai, under which FDC will develop and manufacture generic eye-care drug products in India, and Spectrum will pursue the regulatory approval, marketing and distribution of the approved drugs for sale in the US.
Prescription sales for eye care pharmaceuticals in the US exceed $2bn and continue to grow with the aging population.
'We are excited about entering into a partnership with Spectrum to bring high quality, affordable eye-care alternatives to patients in the US,' stated Nandan Chandavarkar, executive director of FDC. 'Our company finds the US generic ophthalmic and otic market attractive and underserved.'
Under the terms of the agreement, Spectrum has exclusive rights to market and distribute products, mutually agreed upon by both parties, in the US. Initially, the agreement calls for ophthalmic products with plans for expanding the list. The companies expect that at least two ANDA filings with the US FDA on behalf of FDC will occur during 2004.
Spectrum has already identified products on which it plans to begin work immediately, according to Dr Rajesh C. Shrotriya, chairman, ceo and president. 'This diversification into the eye care segment is consistent with our overall strategy of focusing on specialty markets where there is relatively limited competition,' he said.
FDC manufactures ophthalmic and otic drugs in unit and multi-dose packages as well as select active bulk ingredients at an 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 plant in Goa commenced commercial production in September 2000, and was designed to meet MHRA/EU GMP/FDA standards.
FDC is also setting up a second manufacturing plant at a separate site in Goa, which will provide additional capabilities with quality systems meeting international GMP standards. Scale-up runs and commercial production are expected to commence in March 2004.