Bafna Pharma receives Ghana FDA approval for hypertension drug Atenolol

Bafna Pharmaceuticals, (BSE Code: 532989) Chennai-based pharma company engaged in the manufacturing of pharmaceutical formulations of Betalactum and Non–Betalactum, received approval from Ghana Food and Drug Administration (FDA) to market Atenolol 50 mg and Atenolol 100 mg tablets, a hypertension drug. Following this development, it is the 9th formulation approval received from Ghana FDA for a product by Bafna Pharmaceuticals Ltd.

Atenolol is a selective ?1 receptor antagonist, a drug belonging to the group of beta blockers, a class of drugs used primarily in cardiovascular diseases. Atenolol can be used to treat cardiovascular diseases and conditions such as hypertension, coronary heart disease, arrhythmias, angina (chest pain) and to treat and reduce the risk of heart complications following myocardial infarction (heart attack). It is also used to treat the symptoms of Graves Disease, until antithyroid medication can take effect.

Earlier Bafna Pharma received product approval from Ghana FDA, which includes Metformin tablets BP 500mg, Fluconazole tablets 150 mg, Iron tonic fortified with protein, folic acid, Vitamin B12 and Zinc syrup, Haematinic capsules with Vitamins and Zinc, Azithromycin tablets 250mg, Azithromycin tablets 500 mg, Amlodipine Besilate tablets 5mg and Amlodipine Besilate tablets 10 mg.

Commenting on the approval, Mr. Mahaveer Chand Bafna, Chairman and MD of Bafna Pharmaceuticals Ltd. says, “We are extremely pleased to receive FDA approval to market Atenolol tablets 50 mg and 100 mg tablets. It offers an important additional treatment option for physicians and hypertension patients. Following the recent approvals from the FDA in Ghana, Bafna Pharma will be able to widen its customer base in the region.”

Meanwhile, Bafna Pharma has announced its Q2 results. The revenue of the company rose by 35% to Rs. 2279.79 lakhs from Rs. 1688.04 lakhs for the same period last year. Net Profit for the second quarter increased to Rs. 128.99 lakhs from Rs 123.83 lakhs for the same quarter of the previous fiscal year.

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