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US FDA inspects Neuland's Bonthanpally production facility
Our Bureau, Hyderabad | Tuesday, May 18, 2004, 08:00 Hrs  [IST]

The Hyderabad-based Neuland Labs has informed that its facility at Bonthanpally (AP) has been successfully completed the US FDA inspection. The letter of approval is expected in the next few weeks, according to an official release.

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 good quality systems, which enables it to produce large number of products. It has filed 16 DMFs to US FDA, 5 CoS to Council of Europe, 50 registrations in Europe.

Ciprofloxacin has been a key product for the company, and anti depressants are key to the company's growth. Its Anti-psychotic drugs and cardiovascular products are well received in the market. Cardiovascular products are exported to the US and Europe. It has received CoS for Sotalol Hydrochloride from Council of Europe, and has become the only company to have regulatory approval for the product.

The company is planning to have 25-30 products in the next 2-3 years with regulatory approvals. Neuland is to give attention to issues such as developing products of customers with complete confidentiality, offering new drug delivery systems in collaboration with large size companies and MNCs. It is to focus on discovering new products and markets and wants to ensure that the company gets well established in API segment and manufacture of bulk pharmaceuticals. It may venture into new product segments.

Neuland has two manufacturing facilities near Hyderabad. Both facilities comply fully with WHO cGMP standards. It's R&D facility was recognised by the Department of Science & Technology, Government of India, in 1992. The company is recognized by the Govt. 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. It is the first bulk drug manufacturing facility in Andhra Pradesh to receive ISO 9002 certification. It 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.

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