The Hyderabad-based Natco Pharma is expecting the US FDA approval for its Mekaguda (AP) bulk chemicals unit shortly. The US FDA authorities have inspected the manufacture of Sumatriptan Succinate.
The company has also informed that the authorities from Danish Ministry of Health have inspected and approved the manufacture of Ondansetron (4 mg and 8 mg) tablets at its Kothur (AP) formulations plant. As per official sources, the approval allows to market the product in the entire European Union subject to patent validities in EU.
The company has firmed up plans to develop new drug delivery systems (NDDS) and development of new molecules, pertaining to recombinant proteins (useful in cancer therapy), immunosuppressive agents, amino acid derivatives, various analogues and peptides (useful in treating certain CNS disorders) including oligo-peptides, informed the officials.
The company expects that a few of these molecules would reach the phase I clinical trials in the next 9 months. Natco is the second company in South India to have applied for the largest number of patents.