Sun Pharma To Churn Out 4 Bulk Actives

The Mumbai-based Sun Pharmaceuticals is in the process of developing at least four bulk actives by the end of this fiscal.

The drugs will be developed specifically to capture the regulated markets in the US and Europe. The company will file application for these drugs with the USFDA (Food and Drug Administration) and European Pharmaceutical authority for having drug master file (DMF) and certificate of suitability (COS). Success on this front would make Sun a top exporter among Indian pharma companies.

The new initiative will result in a 25-30 per cent growth in exports, driven by business from these bulk actives. In 2000-1, Sun Pharma exports was Rs 118.08 crore against annual turnover of Rs 613.23 crore.

While the company is stronger in formulation sales in the domestic market, it gets bigger business from bulk actives in the export market.

The company has targeted specialty bulk actives that address niche therapy areas for growth. Another benefit of this would be the backward integration for manufacture of formulations, thus reducing dependence on outsourcing and enabling quick product development and launches.

Though the company did not divulge details about the four bulk actives, they would be multi-stage bulk drugs.

There are not too many players in the specific segments, so competition would be less. The bulk actives will be made either at the Ahmednagar plant or Panoli plant.

Bulk-active exports would help Sun enter the formulation markets in developing countries owing to acceptance of its bulk drugs. In Europe and America, DMFs and USFDA-approved plants will help increase exports.

Sun recently received FDA approval for pentoxifylline bulk for peripheral vascular disease. The Ahmednagar plant, too, got FDA approval after a FDA team visited the bulk drug facility in March.