Prostacycline Vasodilator
Where is Treprostinil made?
6 companies sell it under their own name. Their labels name 4 factories in the United States, Italy and India.
United States 2Italy 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| United Therapeutics Corporation Orenitram, Tyvaso, Remodulin, Tyvaso DPI0.125 mg, 0.25 mg, 0.25 mg / 0.125 mg, 1 mg, 1 mg / 0.25 mg / 0.125 mg, 1.74 mg per 2.9 mL · NDC 66302-300, 66302-302, 66302-361 +33 | United Therapeutics CorporationMakes it, tests it, packages it and labels it | Durham, NC, United States | Problems found, fixed voluntarilyFeb 2025 |
| United Therapeutics CorporationMakes it, makes the active ingredient, tests it and labels it | Silver Spring, MD, United States | Problems found, fixed voluntarilyMay 2024 | |
| Alembic Pharmaceuticals Inc.20 mg per 20 mL, 50 mg per 20 mL, 100 mg per 20 mL, 200 mg per 20 mL · NDC 62332-516, 62332-514, 62332-517 +1 | Corden Pharma SpaMakes it | Caponago, Italy | Problems found, fixed voluntarilyMar 2025 |
| Dr. Reddy's Laboratories Inc.20 mg per 20 mL, 50 mg per 20 mL, 100 mg per 20 mL, 200 mg per 20 mL · NDC 43598-647, 43598-649, 43598-648 +1 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Liquidia Technologies, Inc. Yutrepia26.5 ug, 53 ug, 79.5 ug, 106 ug · NDC 72964-014, 72964-011, 72964-012 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.20 mg per 20 mL, 50 mg per 20 mL, 100 mg per 20 mL, 200 mg per 20 mL · NDC 0781-3427, 0781-3420, 0781-3430 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Parenteral Medicines, Inc.20 mg per 20 mL, 50 mg per 20 mL, 100 mg per 20 mL, 200 mg per 20 mL · NDC 0703-0686, 0703-0666, 0703-0696 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 14, 2018 · Class III · United Therapeutics Corp.
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.