Drug
Who makes pramipexole dihydrochloride?
20 companies list pramipexole dihydrochloride as a human prescription drug. Forms: tablet; tablet, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing pramipexole dihydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet; tablet, extended release | ANDAANDA078894, ANDA204518 | 29 | 7 |
| Macleods Pharmaceuticals LimitedIndia | tablet; tablet, extended release | ANDAANDA202164, ANDA206156 | 12 | 5 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA090865, ANDA202633 | 10 | 1 |
| Ingenus Pharmaceuticals, LLC | tablet, extended release | ANDAANDA213444 | 7 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet | ANDAANDA090781 | 6 | 9 |
| Strides Pharma Science LimitedIndia | tablet | ANDAANDA202702 | 6 | 5 |
| Torrent Pharma, Inc.India | tablet | ANDAANDA090865 | 6 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA207011 | 6 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet | ANDAANDA203855 | 6 | 3 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA203855 | 6 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA202633 | 6 | 1 |
| NorthStar RxLLC | tablet, extended release | ANDAANDA206156 | 6 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet, extended release | ANDAANDA203354 | 5 | 15 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA202633 | 4 | 6 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA090865, ANDA202633 | 4 | 3 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA090865 | 3 | 5 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA090781 | 2 | 1 |
| Xiamen LP Pharmaceutical Co., Ltd.China | tablet, extended release | ANDAANDA212797 | 2 | 1 |
| Vitruvias Therapeutics, Inc. | tablet, extended release | ANDAANDA212797 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA090865 | 1 | 0 |
Bulk ingredient listings
- Aurobindo Pharma LimitedIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
Orange Book patents
2 unexpired patents list pramipexole dihydrochloride as the active ingredient, expiring between Apr 2028 and Sept 2029. Application holder: BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes pramipexole dihydrochloride?
- 20 companies list pramipexole dihydrochloride as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Macleods Pharmaceuticals Limited, Bryant Ranch Prepack, Ingenus Pharmaceuticals, LLC, Glenmark Pharmaceuticals Inc., USA. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic pramipexole dihydrochloride?
- 20 companies list pramipexole dihydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies pramipexole dihydrochloride active ingredient?
- 6 companies list pramipexole dihydrochloride as a bulk ingredient, including Aurobindo Pharma Limited, Curia India Private Limited, Hetero Drugs Limited, MSN Laboratories Private Limited,.