The Chennai based Bafna Pharmaceuticals, engaged in the business of manufacturing of pharmaceutical formulations of betalactum and non–betalactum, has received approval from Ghana Food and Drug Administration (FDA) for metformin tablets 500mg, a drug used by the diabetic patients.
This is the 8th formulation approval received from Ghana FDA for a product by Bafna Pharmaceuticals. Recently Bafna Pharma had 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, Mahaveer Chand Bafna, chairman and MD of Bafna Pharmaceuticals Ltd. said, “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 generic metformin product, which will provide consumers with an affordable price. The approval of metformin tablets represents yet another addition to the expanding Bafna Pharma product portfolio”.
According to sources from the company, it 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 per cent Export Oriented Unit (EOU) and a EU GMP (UK MHRA), facility at Grantlyon, Chennai.
A few months ago, 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.
In April 2010, Bafna inaugurated its Research and Development (Formulation) (FR&D) facility, a pilot plant in Chennai.