Sandoz files seven ANDAs of drugs going off-patent

EPP News Bureau - Mumbai

Mumbai-based Sandoz Private—a wholly-owned subsidiary of Novartis AG—has applied for seven Abbreviated New Drug Applicatons (ANDAs) for products likely to go off-patent in the next three to five years.

The move is seen as a global generic company replicating the Indian generic revenue model for its operations in India. This was disclosed by Sandoz worldwide chief executive officer Andreas Rummelt here. Dr Rummelt during his visit, is travelling to all the Novartis/Sandoz facililties located in India.

The Indian model has been followed by companies like Ranbaxy, Cipla, Sun Pharma and Dr Reddy’s Labs to get a pie of the regulated market and it is now the turn of global generic majors to imitate Indian revenue models.

The filing of the ANDAs comes at a time when the Sandoz facility at Kalwa, on the outskirts of Mumbai, has received US FDA approval.

Sandoz in India is also setting up a multi-purpose plant for active pharma ingredient at Mahad in Maharashtra to be operational by 2007. The company has facilities at Kolshet, Kalwa, Mahad and Turbe in Maharashtra, employing around 1,000 people. The Mahad facility, equiped with the rifampicin plant, was transferred to Sandoz from Novartis India. Since rifampicin prices are under the control of the drug regulatory authority, the company is finding it difficult to sustain the plant.

Sandoz was globally formed in May 2003 when 14 individual companies within the Novartis group worldwide, were re-branded to create a world-class entity. Now, Novartis primarily operates through two business units with specific strategic focus on anti-infectives and biopharmaceuticals.

Sandoz has globally reported 12 per cent growth in its sales in the first quarter of 2005 to $803 million and a 21 per cent increase in operating income to $110 million.

The company has entered into agreements to acquire 100 per cent of Hexal AG, the privately-held number two generics company in Germany with a strong European presence and a 67.7 per cent stake in Eon Labs, a fast-growing US generics company.