Strides Arcolab files 11 ANDAs/NDAs with US FDA in first half of 06
Strides Arcolab, the branded generic export major filed 11 Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) through its partners and directly with the US FDA in the first half of 2006 and one in 2005.
The company which has a focus on AIDS and malaria drug development and supply managed to get the approval for its fifth HIV product from the World Health Organization.
The first quarter of 2006, saw the company get on to an acquisition mode. It laid its hands on the Valeant facility in Poland. Then it entered into a joint venture initiative with Turkey's leading pharmaceutical company Abdi Ibrahim set up a JV company called Abdi-Strides. This was primarily to exploit the Turkish market for Strides' range of specialized products. The company also struck a global joint venture to develop generics using Accu-Break technologies with Accu-Break Pharmaceuticals, Inc.
The company manufactures formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of softgel capsules. It has the only globally dedicated soft gel facility for hormones. In addition, it undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. The company has a major presence in Africa, Latin America, Asia, US, Canada and part of Europe. This apart the company is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the World Bank, the African Development Bank and UNICEF, amongst others.
The ISO 9001, ISO 14001 company with GMP and USFDA certified accreditations has 13 manufacturing plants spread across the US, Brazil, Mexico, Italy, Poland and India. The manufacturing network facilitates partnering with global organizations ranging like UNICEF and WHO-Global Drug Facility to Europe and US pharmaceutical multinationals apart from private labellers and distribution chains, stated the company.
In addition, the company has product registrations in over 37 countries apart from a marketing presence in 50 countries. It employs around 1,700 people which includes global sites.