Mumbai, July 8: Lupin Ltd is on course to enhance its product offering in the US and European markets to include non-cephalosporin oral dosage forms. The company today announced that its non-cephalosporin oral dosage facility at Goa has passed the US Food and Drug Administration (USFDA) test.

The Goa facility, commissioned in March 2004, was set up to facilitate Lupin’s foray into advanced markets with non-cephalosporin oral dosage forms.

The Goa facility will be the company’s eleventh plant to receive USFDA approval. Earlier, the USFDA had approved its non-cephalosporin API (active pharmaceutical ingredients) plant at Tarapur in Maharashtra.

Lupin’s managing director Kamal K. Sharma said, “The clearance by the US authority will enable Lupin to significantly enhance its product offering in the US, the European Union and other advanced markets.”

Meanwhile, Lupin had posted net sales of Rs 1,161 crore for the year ended March 31. While its revenues from the advanced markets of North America and Europe, in both APIs and finished dosages, during the year was Rs 202 crore, it was Rs 951.9 crore from the developing markets (including India).

Over the last fiscal, the company had spent 6.9 per cent of its net sales on research and development and filed 14 abbreviated new drug applications (ANDAs). Lupin had already got the approval for five ANDAs and four drug molecules are in the clinical trial stage.

The company had received the approval of the Drug Controller General of India (DCGI) last December for conducting phase I clinical trials for two of its new drug molecules, LL 4858 and LL 4218.

LL 4858 is an anti-TB drug and pre-clinical studies show that the ailment can be treated faster with it with low adverse effects than the existing anti-TB therapy. LL 4218 is for the treatment of a chronic skin condition, known as psoriasis.

Apart from these, the company is also focussing on NCE research for inflammatory disorders, respiratory diseases and anti-bacterials.

Last fiscal, Lupin’s wholly owned subsidiary, Lupin Pharmaceuticals Inc (LPI), had entered into a promotional tie-up with Cornerstone BioPharma Inc for the US market for its Suprax (cefixime) anti-infective drug. According to the agreement, Cornerstone’s sales force will co-promote Suprax with a focus on primary care physicians.

Lupin also entered into an in-licensing agreement with Cornerstone for clinical development of a novel drug delivery system (NDDS) for an anti-infective product.

On the Bombay Stock Exchange today, the Lupin scrip closed at Rs 704.05 after opening at Rs 698 and rising to an intra-day high of Rs 709.90.