Drug
Who makes omega-3-acid ethyl esters?
17 companies list omega-3-acid ethyl esters as a human prescription drug. Forms: capsule; capsule, liquid filled. 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 omega-3-acid ethyl esters
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | capsule, liquid filled | ANDAANDA207420, ANDA210093 | 5 | 3 |
| Bryant Ranch PrepackUnited States | capsule, liquid filled | ANDAANDA206455, ANDA207420, ANDA210093 | 4 | 1 |
| KD Pharma Canada LTDUnited States | capsule | ANDAANDA091028, ANDA212504 | 2 | 1 |
| RemedyRepack, IncUnited States | capsule, liquid filled | ANDAANDA207420, ANDA210093 | 2 | 1 |
| Par Health USA, LLCIndia | capsule | ANDAANDA203893 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA203893 | 1 | 5 |
| Strides Pharma Science LimitedIndia | capsule | ANDAANDA203893 | 1 | 5 |
| Epic Laboratories, LLCUnited States | capsule, liquid filled | ANDAANDA210093 | 1 | 3 |
| Bionpharma Inc.India | capsule, liquid filled | ANDAANDA206455 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule, liquid filled | ANDAANDA207420 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA091028 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | capsule, liquid filled | ANDAANDA210093 | 1 | 1 |
| XLCare Pharmaceuticals Inc.United States | capsule, liquid filled | ANDAANDA207420 | 1 | 1 |
| Chartwell RX, LLC. | capsule, liquid filled | ANDAANDA211355 | 1 | 0 |
| Lifestar Pharma LLC. | capsule, liquid filled | ANDAANDA215458 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, liquid filled | ANDAANDA215458 | 1 | 0 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | capsule, liquid filled | ANDAANDA210093 | 1 | 0 |
Bulk ingredient listings
- BASF AS avd SandefjordNorway · 2 NDC
- Huatai Biopharm Inc.China · 1 NDC
- K.D. Pharma Bexbach GmbHGermany · 1 NDC
- KinOmega Biopharm Inc.China · 1 NDC
- Shandong Xinhua Pharmaceutical Company LimitedChina · 1 NDC
Enquiry
Common questions
- Who makes omega-3-acid ethyl esters?
- 17 companies list omega-3-acid ethyl esters as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, KD Pharma Canada LTD, RemedyRepack, Inc, Par Health USA, 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 omega-3-acid ethyl esters?
- 17 companies list omega-3-acid ethyl esters 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 omega-3-acid ethyl esters active ingredient?
- 5 companies list omega-3-acid ethyl esters as a bulk ingredient, including BASF AS avd Sandefjord, Huatai Biopharm Inc., K.D. Pharma Bexbach GmbH, KinOmega Biopharm Inc..