Aurobindo Pharma’s Unit 3 formulations manufacturing facility has been approved by Medicines and Healthcare products Regulatory Agency, UK (previously known as UK MCA) for manufacture of formulations for UK market.
The Unit 3, which is located at Hyderabad is spread over eight acres and the working area of the unit in two production blocks and five modules measures about 1,20,000 sq. ft with a capacity of around 2.7 billion tablets/capsules per year. The unit is dedicated for non-penicillins and non- cephalosporin dosage formulations.
It is important to note that Unit 3 has also been approved by South African MCC and Brazilian ANVISA in addition to ISO and approvals from several other countries.
Aurobindo received its first COS approval from European Directorate of Quality Medicines (EDQM). Now, with the clearances for the dosage formulation facility, the journey into regulated markets has begun for the company, starting with European market.
Aurobindo has filed several dossiers with European authorities for its APIs and formulations. It has made significant investments to penetrate into Europe, USA, China and Brazil in the last three years.
With the beginning of clearances from EDQM and MHRA and the commencement of full-fledged operations in China in September 2003, the company is looking forward to its payback from these two segments from March 2004 onwards.