Drug
Who makes ranolazine?
27 companies list ranolazine as a human prescription drug, including under the names ASPRUZYO SPRINKLE. Forms: granule; tablet, extended release; tablet, film coated, 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 ranolazine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | granule; tablet, extended release | ANDA, NDAANDA211707, NDA216018 | 3 | 13 |
| Proficient Rx LPUnited States | tablet, film coated, extended release | ANDAANDA211829 | 3 | 1 |
| Lupin LimitedIndia | tablet, film coated, extended release | ANDAANDA201046 | 2 | 14 |
| Zydus Lifesciences LimitedIndia | tablet, extended release | ANDAANDA210188 | 2 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated, extended release | ANDAANDA211082 | 2 | 9 |
| Torrent Pharma, Inc.India | tablet, film coated, extended release | ANDAANDA214035 | 2 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated, extended release | ANDAANDA213083 | 2 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet, film coated, extended release | ANDAANDA211829 | 2 | 3 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA210054 | 2 | 2 |
| Bryant Ranch PrepackUnited States | tablet, extended release; tablet, film coated, extended release | ANDAANDA210188, ANDA213517 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated, extended release | ANDAANDA212788 | 2 | 1 |
| Radha Pharmaceuticals, Inc.United States | tablet, film coated, extended release | ANDAANDA211829 | 2 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | tablet, extended release | ANDAANDA214551 | 2 | 1 |
| A2A Integrated Pharmaceuticals, LLC | tablet, film coated, extended release | ANDAANDA213517 | 2 | 0 |
| ASCEND Therapeutics US, LLC | tablet, film coated, extended release | ANDAANDA209953 | 2 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated, extended release | ANDAANDA211829, ANDA212781 | 2 | 0 |
| AvKARE | tablet, film coated, extended release | ANDAANDA212781 | 2 | 0 |
| AvPAK | tablet, film coated, extended release | ANDAANDA209953 | 2 | 0 |
| Lifestar Pharma LLC. | tablet, film coated, extended release | ANDAANDA212284 | 2 | 0 |
| SunGen Pharma LLC | tablet, film coated, extended release | ANDAANDA212781 | 2 | 0 |
| Viona Pharmaceuticals Inc. | tablet, extended release | ANDAANDA210188 | 2 | 0 |
| Westminster Pharmaceuticals, LLC | tablet, film coated, extended release | ANDAANDA211829 | 2 | 0 |
| Zameer Pharmaceuticals LLC | tablet, film coated, extended release | ANDAANDA213085 | 2 | 0 |
| i3 Pharmaceuticals, LLC | tablet, film coated, extended release | ANDAANDA213517 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, extended release | ANDAANDA210054 | 1 | 5 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, extended release | ANDAANDA210188 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated, extended release | ANDAANDA209953 | 1 | 0 |
Bulk ingredient listings
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 2 NDC
- Zydus Lifesciences LimitedIndia · 2 NDC
- AARTI PHARMALABS LIMITEDIndia · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- COSMA SpA · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- MSN Pharmachem Private LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Union Quimico Farmaceutica SASpain · 1 NDC
- VIRUPAKSHA ORGANICS LIMITEDIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
3 unexpired patents list ranolazine as the active ingredient, expiring between Jan 2038 and Jan 2038. Application holder: SUN PHARMA INDUSTRIES LTD.
Enquiry
Common questions
- Who makes ranolazine?
- 27 companies list ranolazine as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Proficient Rx LP, Lupin Limited, Zydus Lifesciences Limited, 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 ASPRUZYO SPRINKLE?
- 27 companies list ranolazine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies ranolazine active ingredient?
- 19 companies list ranolazine as a bulk ingredient, including FIS FABBRICA ITALIANA SINTETICI SPA, Zydus Lifesciences Limited, AARTI PHARMALABS LIMITED, Alivus Life Sciences Limited.