The Hyderabad-based Neuland Laboratories has received US FDA approval for its Bonthanpally facility in Andhra Pradesh. The company informed the development to BSE on Friday. The US FDA team has inspected the company's facilities during May 2004.
Neuland has been offering contract research services to 3-4 large generic companies in US and Canada. Over 50 per cent of the company's major products are developed through contract research. It has filed 16 DMFs to US FDA, 5 CoS to Council of Europe, 50 registrations in Europe.
Neuland's R&D facility was recognised by the Department of Science & Technology, Government of India, in 1992. The company is recognized by the Government of India as an export house. The company has supplied its products to customers around the globe. Prominent markets include USA, Canada, Germany, France, United Kingdom, Italy, Korea, Japan, Taiwan, Australia, South Africa, Turkey, Jordan, Iran, Egypt, Brazil, Argentina, Mexico, and also East European countries, officials informed.
Neuland is the largest manufacturer of Albuterol Sulfate (Salbutamol Sulphate) in the world with US FDA approval and Certificate of Suitability from the European Department for the Quality of Medicines, Council of Europe.