Tadalafil

Overview

Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. It helps in relaxing muscles of the blood vessels, increasing blood flow to specific areas of the body.

API suppliers (25)

Suppliers of Tadalafil evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• ALIVUS LIFE SCIENCES LTDIndia2 active DMF GMP on record
• MSN Organics Private LimitedIndia2 active DMF
• TAPI NL BVNetherlands1 active DMF
• Orchid Pharma LimitedIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Shandong Anxin Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• SHANDONG LUNING PHARMACEUTICAL CO LTD1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• SMS Pharmaceuticals limitedIndia1 active DMF GMP on record
• ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• Apotex Pharmachem India Pvt. Ltd.India1 active DMF
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• HONOUR LAB LTDIndia1 active DMF GMP on record
• AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)India1 active DMF
• TOPHARMAN SHANDONG CO LTDChina1 active DMF
• Zhejiang Yongning Pharmaceutical Co., LtdChina1 active DMF
• AZICO BIOPHORE INDIA PRIVATE LTD1 active DMF
• Shandong New Time Pharmaceutical Co Ltd1 active DMF GMP on record
• AMI LIFESCIENCES PRIVATE LTDIndia1 active DMF GMP on record
• DR REDDYS LABORATORIES LTD GMP on record
• AMI LIFE SCIENCES PRIVATE LTD

EU CEP holders (20)

Companies holding a valid EU Certificate of Suitability (CEP) for Tadalafil, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (122 approved US products), the latest listed US patent on Tadalafil expires 24 Dec 2038. Generic API sourcing typically opens up once these lapse.

Therapeutic areas