Bafna Pharmaceuticals, Chennai-based pharma company engaged in the manufacturing of pharmaceutical formulations of betalactum and non–betalactum, has 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. Recently the company received approval for amlodipine 5 mg and 10 mg.
Commenting on the approval, Mahaveer Chand Bafna, chairman and MD, said, “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 5a-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.