Natco's Mekaguda API plant gets US FDA nod

Hyderabad-based Natco Pharma Limited today announced that its active pharmaceutical ingredients (API) plant at Mekaguda, in Mahaboobnagar district has received US FDA approval.

The company, which has been growing at a compound annual growth rate (CAGR) of about 25 per cent, is now focusing on high-value low-volume drugs in the finished dosage formulation in the oncology segment.

In order to take advantage of the large number of products that would be going off patent in 2005, Natco has elaborate plans to mark its presence in the regulated markets of the US and the UK.

The company has already filed seven DMFs (drug master files) and proposes to file another six by the end of the current fiscal. The DMFs according to a company press release pertain to anti-depressants, anti-emetic and anti-cancer drugs.

The company has already received approval from the Danish Health Ministry for marketing of Ondanestron 4 mg / 8 mg tablets and is expected to open up the European market for the company.

Natco has also received the UK regulator, Medicine and Health Regulatory Agency's marketing approval for its Metronidazole 400 mg tablets.

The company, according to the press release, is also actively pursuing the steps connected with compliance with the Mutual Recognition Protocol in Europe for approval from other European Union countries.

The company expects its modern plant at Kothur to be inspected by the US FDA nod in the next couple of months and the final approvals to be got before the end of the current fiscal.

The US and the European markets are huge and estimated to be in the region of $60 billion. Natco expects to put in place tie-ups with product specific generic companies, with whose help and assistance it should be possible to garner a share of the market.

Natco has drawn up elaborate expansion plans with a new production block being constructed at Mekaguda, in conformity with FDA standards, with eight modules of pharma rooms.

To be completed in June 2005, the company's API facility will be equipped with twelve modern modules. Additional capacity is also being added at the formulations unit at Kothur providing for eight additional modules.