Bafna Pharmaceuticals, Chennai-based pharma company engaged in the business of manufacturing of pharmaceutical formulations of beta-lactum and non–beta-lactum, has received approval from Medicines and Healthcare products Regulatory Agency of the UK (UK MHRA) for manufacturing clonazepam 0.5 mg and 2 mg tablets. Following this development, it is the ninth formulation approval received from UK MHRA for a product by the company for contract manufacturing.
Commenting on the approval, Mahaveer Chand Bafna, chairman and MD of Bafna Pharmaceuticals, said, “The approval from UK MHRA will provide further momentum to our already expanding business in the European market. UK MHRA approval will enable Bafna Pharma to widen the customer base in Europe. Following the recent launch of our R&D facility in Chennai, we will be filing dossiers for the ever growing UK and the European markets.”
Clonazepam tablet is a nitrobenzodiazepine derivative with anticonvulsant, muscle relaxant and anxiolytic properties. It is generally considered to be among the long-acting benzodiazepines. It may be prescribed for epilepsy, anxiety disorders, panic disorder, initial treatment of mania or acute psychosis, hyperekplexia, many forms of parasomnia, restless legs syndrome, bruxism, rapid eye movement behaviour disorder.
The company has over 76 products registered in Sri Lanka, Ukarine, Lao and Ghana. The company has two manufacturing facilities. A WHO-GMP certified manufacturing facility in Madhavaram, which is a 100 per cent export oriented unit (EoU) and an EU GMP facility at Grantlayan, Chennai. Recently the company received the Good Manufacturing
The company has inaugurated its Research and Development (Formulation) facility, a pilot plant in Chennai during April 2010. The company has secured ISO 9001: 2008 Certificate of Registration for Manufacture and Export of Pharmaceutical products. Bafna Pharma has also received EU GMP Compliances from (MHRA) Medicines and Healthcare products Regulatory Agency, UK. This accreditation has made Bafna Pharmaceuticals the 35th facility to achieve this key recognition in India and has opened the gates for exploring markets of European Union.