Tadalafil

CAS 171596-29-5 26 FDA-DMF suppliersSmall Molecule

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 (22)

Suppliers of Tadalafil backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

  • SHANDONG XINHUA PHARMACEUTICAL CO LTDChina3 active DMF
  • AMOLI ORGANICS PRIVATE LTD2 active DMF
  • ALIVUS LIFE SCIENCES LTD2 active DMF
  • JBC Pharmaceuticals Ltd.United Kingdom1 active DMF
  • Zakłady Farmaceutyczne Polpharma S.A.Poland1 active DMF
  • MATRIX PHARMACORP PRIVATE LTD1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • MATRIX PHARMACORP PRIVATE LTD1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • APITORIA PHARMA PRIVATE LTDIndia1 active DMF
  • MATRIX PHARMACORP PRIVATE LTD1 active DMF
  • TAPI NL BV1 active DMF
  • Orchid Pharma LimitedIndia1 active DMF
  • Alembic Pharmaceuticals LimitedIndia1 active DMF
  • MATRIX PHARMACORP PRIVATE LTD1 active DMF
  • TAPI NL BV1 active DMF
  • Orchid Pharma LimitedIndia1 active DMF
  • Alembic Pharmaceuticals LimitedIndia1 active DMF
  • JBC Pharmaceuticals Ltd.United Kingdom1 active DMF
  • Zakłady Farmaceutyczne Polpharma S.A.Poland1 active DMF
  • Dr. Reddy's Laboratories Ltd.India
  • AMI LIFE SCIENCES PRIVATE LTD

Patent & exclusivity (US)

Per the FDA Orange Book (121 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

Erectile DysfunctionPulmonary HypertensionBenign Prostatic Hyperplasia

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