KNATCO Pharma Ltd (NPL), the Hyderabad-based Rs 154-crore pharmaceutical company, has announced that it has obtained the approval from the United States Food and Drugs Authority (USFDA) for its active pharmaceutical ingredients (APIs) manufacturing facility located at Mekaguda in Mahaboobnagar district of Andhra Pradesh.

In a press release here on Monday, Natco said with the USFDA approval it gained gateway to the Western markets. Post 2005, taking advantage of the large number of products that would be going off patent, the company plans to penetrate into the UK and US markets.

The company has already received approval from the Danish Health Ministry for marketing of Ondansetron in 4 mg and 8 mg tablets form, opening the European Gateway for the company. Natco has also received UK Medicine & Health Regulatory Agency's marketing approval for its Metronidazole in 400 mg tablets form.

Stating that it has already filed seven drug master files (DMFs) with the USFDA and proposes to file another six DMFs by the current fiscal-end, essentially in the area of anti-depressants, anti-emetic and anti-cancer therapies, the company said it was actively pursuing steps connected with the compliance with the Mutual Recognition Protocol in Europe for approvals from more EU countries.

Natco said its modern FDA compliant formulation facility at Kothur near here was slated for inspection by the USFDA authorities during the next couple of months. Expecting the approvals in hand by the end of the current fiscal, the company said it would give added impetus to its global marketing efforts.

Meanwhile, the company said it has drawn up elaborate expansion plans, which includes new production block at Mekaguda in conformity with FDA standards with eight modules of pharma rooms. The expansion was expected to be ready by June next year and company's API facility would be equipped with 12 modern pharma rooms.

Further, the company is also planning additional capacity at the formulation facility of Kothur providing for eight additional modules.

In addition, the company is also planning the construction of a dedicated anti-cancer and anti-viral block and a separate block for chemical intermediates. On completion of this expansion, the company's facility would become one of the biggest and modern in both APIs and finished dosage formulations, the release said.