Drug
Who makes simvastatin?
27 companies list simvastatin as a human prescription drug, including under the names ZOCOR. Forms: tablet, film coated. 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 simvastatin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA077691, ANDA078034, ANDA078103 | 24 | 3 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA077691, ANDA078034, ANDA078103 | 13 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA078034, ANDA078103, ANDA078155 | 12 | 0 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA077691, ANDA078103, ANDA078155 | 10 | 1 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA077691, ANDA078034, ANDA078103 | 7 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA077691, ANDA078103, ANDA078155 | 7 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078103, ANDA078155 | 6 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA078034, ANDA078103 | 6 | 1 |
| Lupin LimitedIndia | tablet, film coated | ANDAANDA078103 | 5 | 14 |
| Biocon Biologics LimitedIndia | tablet, film coated | ANDAANDA078034 | 5 | 9 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA078155 | 5 | 2 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA200895 | 5 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA078034 | 5 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA200895 | 5 | 1 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA077691 | 5 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet, film coated | ANDAANDA200895 | 5 | 0 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA077691 | 4 | 6 |
| Westminster Pharmaceuticals, LLC | tablet, film coated | ANDAANDA211394 | 4 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA078103 | 3 | 5 |
| Organon LLCNetherlands | tablet, film coated | NDANDA019766 | 3 | 4 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA078103 | 3 | 1 |
| Direct RxUnited States | tablet, film coated | ANDAANDA078103 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA078103 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078103 | 3 | 1 |
| QPharma IncUnited States | tablet, film coated | ANDAANDA078103, ANDA078155 | 3 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA078103 | 3 | 1 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA078103 | 1 | 34 |
Bulk ingredient listings
- AX Pharmaceutical CorpCanada · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- Henan Topfond Sci-Tech Co., Ltd.China · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Teva Pharmaceutical Works Private Limited CompanyHungary · 1 NDC
- Zhejiang Jiangbei Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
2 unexpired patents list simvastatin as the active ingredient, expiring between Apr 2027 and Feb 2030. Application holder: SALERNO PHARMACEUTICALS.
Enquiry
Common questions
- Who makes simvastatin?
- 27 companies list simvastatin as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, NuCare Pharmaceuticals,Inc., Northwind Health Company, LLC. 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 ZOCOR?
- 26 companies list simvastatin 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 simvastatin active ingredient?
- 9 companies list simvastatin as a bulk ingredient, including AX Pharmaceutical Corp, Aurobindo Pharma Limited, Biocon Biologics Limited, Henan Topfond Sci-Tech Co., Ltd..