Two of Sun Pharma's factories recently received clearance from the US FDA without a single adverse remark or observation (technically called a 483 observation). Both the Panoli bulk active and Halol tablet manufacturing factories were inspected and cleared by the US FDA. With this addition, now three of the company's factories including the Ahmednagar site can be used for the US market.

This US FDA approval is the second major international approval for the Panoli factory. European regulatory authorities have earlier approved this factory. Large innovator companies across Europe have been sourcing material from here.

The clearance for formulations at Halol is the company's first US FDA clearance for an Indian tableting facility. The Halol factory has approvals from regulatory authorities like the UK MCA, Brazilian ANVISA, Columbian INVIMA, and South African MCC.

Sun Pharma will participate in the $16 billion US generic market both through the 63 per cent subsidiary Caraco Pharmaceutical Labs and this Indian factory.

"This approval significantly strengthens the company's international dosage form plans," said Dilip Shanghvi, CMD, Sun Pharma.

Sun Pharma is ranked 5th among all Indian pharma companies with a 3.12 per cent MS (IMS-ORG Retail Chemist Audit, April 2004). International markets account for 30 per cent of turnover (with Caraco turnover) In niche therapy areas such as psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics, Sun Pharma ranks among the top 3 companies.

The company has strong initiatives planned in research, with additional 250,000 sq ft of research floor area across 2 new sites added this year, 320 strong scientist staff, projects in human trials and continuing commitments of $15 mill to R&D for each of the next two years.