Bafna Pharmaceuticals, (BSE Code: 532989) Chennai-based pharma company engaged in the business of manufacturing of pharmaceutical formulations of Betalactum and Non–Betalactum received approval from Ghana Food and Drug Administration (FDA) for Metformin tablets 500mg, a drug used by the diabetic patients. Following this development, it is the 8th formulation approval received from Ghana FDA for a product by Bafna Pharmaceuticals Ltd. Recently Bafna Pharma received the Australian Therapeutic Goods Administration (TGA) approval on manufacturing of both Prescription and Non-Prescription products in the Australian market.
Metformin is an oral anti-diabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of type 2 diabetes, particularly in overweight and obese people and those with normal kidney function. Evidence is also mounting for its efficacy in gestational diabetes. It is also used in the treatment of polycystic ovary syndrome and has been investigated for other diseases where insulin resistance may be an important factor.
Commenting on the approval, Mr. Mahaveer Chand Bafna, Chairman and MD of Bafna Pharmaceuticals Ltd. says, “This is a wonderful opportunity for Bafna Pharma to introduce another affordable product like Metformin in Ghana healthcare system. We look forward of launching our formulation Metformin tablets 500mg shortly. The approval of Metformin tablets represents yet another addition to the expanding Bafna Pharma product portfolio”.
About Bafna Pharmaceuticals Ltd:
The company has 80 products registered in UK, Sri Lanka, Ukraine, Lao, Ghana, Ethiopia, Philippians and Nigeria. The company has two manufacturing facilities. A WHO-GMP certified manufacturing facility in Madhavaram, which is a 100 percent Export oriented Unit (EOU) and an EU GMP (UK MHRA), facility at Grantlyon, Chennai. Recently, the company received Australian TGA approval and also received the Good Manufacturing Practices (GMP) approval from Ethiopia’s Drug Administration and Control Authority (DACA) for its non-betalactam facility.
The company in the month of April 2010 inaugurated its Research and Development (Formulation) (FR&D) facility, a pilot plant in Chennai. 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, U.K. 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
