The Hyderabad-based bulk drugs player Neuland Laboratories Ltd has filed drug master files (DMFs) with the US Food and Drugs Administration (US FDA) for enlapril maleate, itraconazole and ofloxacin bulk drugs in the last two months. The filing of DMF is a first and important step to get US FDA approval for a bulk drug.
Confirming the filing of DMFs for three products, a senior official of the Neuland Labs said that the company is expecting the FDA approval for its ciprofoxacin HCL in the near future. The company filed DMF for ciprofloxacin in 1998. Two customers have come forward to use the Neuland's product and have filed abbreviated new drug applications (ANDAs). Ciprofloxacin will go out of patent in early 2003.
Neuland Labs had earlier received US FDA approval for rantidine form I and albeturol sulphate (Salbutamol). The company had also filed DMFs for ipratropium bromide, rantidine Form II and sotalol during the last year. The company has initiated measures to file the required applications in other regulated markets.
"These filings are in line with our business plan to have all new products ultimately marketed in the regulatory markets. Appropriate investments in plant and machinery and lab are being made to enable this," the official said. The company has developed process technologies for mitazapine, olanzapine, fluticasone and ramipril bulk drugs to expand the product portfolio. As of now, the main products of the company are salbutamol, ciprofloxacin and rantidine.
Neuland Labs recorded a net profit of Rs 2 crore, after making an extraordinary provision of Rs 2.35 crore for foreign exchange loss on ECB payment, on a turnover of Rs 90 crore in 2000-01. For the current fiscal, the company is aiming at an operating profit of Rs 10 crore compared with Rs 7 crore in the last fiscal on a turnover of over Rs 100 crore. "Our first quarter performance is in line with the annual target," the official said.
