Bafna Pharmaceuticals, Chennai-based pharma company engaged in the manufacturing of pharmaceutical formulations of b and non–betalactum, has received approval from UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture Amlodipine 5mg and Amlodipine 10mg. This is its 13th formulation approval from MHRA.
Recently Bafna Pharma received approval from Ghana Food and Drug Administration (FDA) to market a hypertension drug Atenolol 50 mg and Atenolol 100 mg tablets.
Amlodipine is a long-acting calcium channel blocker (dihydropyridine class) used as an anti-hypertensive and in the treatment of angina. Amlodipine acts by relaxing the smooth muscle in the arterial wall, decreasing total peripheral resistance and hence reducing blood pressure; in angina it increases blood flow to the heart muscle. Amlodipine is indicated in hypertension and Angina pectoris. It is also used in combination with other anti hypertensives.
Commenting on the approval, Mahaveer Chand Bafna, chairman and MD,said, “The approval from UK MHRA for Amlodipine 5mg and Amlodipine 10mg will provide further drive to our current expansion efforts in the European region. UK MHRA approval will enable Bafna Pharma to widen the customer base in Europe.”
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 per cent 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.