Bafna further expands into European market with yet another formulation

Receives 14th UK MHRA approval to manufacture Finasteride 5mg

Bafna Pharmaceuticals, (BSE Code: 532989) Chennai-based pharma company engaged in the manufacturing of pharmaceutical formulations of Betalactum and Non–Betalactum is proud to announce an addition of a product approval to its kitty. Following the recent approval of Amlodipine 5mg and Amlodipine 10mg, Bafna Pharma has now received 14th approval from UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture Finasteride 5mg. Finasteride is used in Benign Prostatic Hypertrophy (BPH) or enlargement of the prostate gland.

Commenting on the approval, Mr. Mahaveer Chand Bafna, Chairman and MD of Bafna Pharmaceuticals Ltd. says, “For patients with BPH whose disease is worsening and whose symptoms are moderate-to-severe, Finasteride offers the benefits of both medicine, and provides doctors with an effective treatment option. Bafna Pharma has been constantly upgrading its manufacturing facilities to efficiently meet the anticipated demands of the global markets. The approval from UK MHRA for Finasteride 5mg will enable Bafna Pharma to widen the customer base in Europe.”

Finasteride 5 mg tablets is a prescription-only medicine (POM) used for the treatment and control of Benign Prostatic Hyperplasia in order to cause regression of an enlarged prostate and improvement of other symptoms associated with BPH. It is also used to reduce the need for BPH-related surgical procedures in patients.

Finasteride is an orally active testosterone 5-alpha-reductase inhibitor. It is an azasteroid, a synthetic anti-androgen that acts by inhibiting type-2 isoform of 5?-reductase the enzyme that converts testosterone to dihydrotestosterone. It is used as a surgical alternative for treatment of Benign Prostatic Hyperplasia (BPH). In patients with BPH, it reduces dihydrotestosterone concentrations in blood and consequently reduces prostatic volume and improves urinary flow. Finasteride reduces prostatic size by a combination of atrophy and apoptosis. It also reduces detrusor pressure in patients with bladder outlet obstruction by BPH.

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