Drug
Who makes ramelteon?
25 companies list ramelteon as a human prescription drug, including under the names Rozerem. Forms: tablet; 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 ramelteon
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA091693, ANDA211567, ANDA212650 | 10 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet; tablet, film coated | ANDAANDA211567, ANDA215243, ANDA215972 | 3 | 1 |
| Direct RxUnited States | tablet; tablet, film coated | ANDAANDA211567, ANDA212650, ANDA213815 | 3 | 1 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA212650, ANDA213815 | 2 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA212650, ANDA213186 | 2 | 1 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA211567 | 1 | 12 |
| Granules Pharmaceuticals Inc.India | tablet | ANDAANDA213186 | 1 | 8 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | tablet, film coated | NDANDA021782 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA215972 | 1 | 6 |
| Micro Labs LimitedIndia | tablet | ANDAANDA215243 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA211567 | 1 | 5 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA216209 | 1 | 1 |
| Marlex Pharmaceuticals, IncUnited States | tablet, film coated | ANDAANDA215435 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA213815 | 1 | 1 |
| Xiromed LLCIndia | tablet, film coated | ANDAANDA216209 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA211567 | 1 | 1 |
| Advanced Rx of Tennessee, LLC | tablet | ANDAANDA215243 | 1 | 0 |
| AvKARE | tablet | ANDAANDA213186 | 1 | 0 |
| AvPAK | tablet | ANDAANDA215243 | 1 | 0 |
| Kanchan Healthcare Inc | tablet, film coated | ANDAANDA215435 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA211567 | 1 | 0 |
| Sportpharm LLC | tablet | ANDAANDA215243 | 1 | 0 |
| TruPharma LLC. | tablet, film coated | ANDAANDA212650 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet, film coated | ANDAANDA213815 | 1 | 0 |
| i3 Pharmaceuticals, LLC | tablet, film coated | ANDAANDA212650 | 1 | 0 |
Bulk ingredient listings
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 3 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Biophore India Pharmaceuticals Private LimitedIndia · 1 NDC
- Cutyx Research LLPIndia · 1 NDC
- Enaltec Labs Private LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
Enquiry
Common questions
- Who makes ramelteon?
- 25 companies list ramelteon as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, ASCLEMED USA INC. DBA ENOVACHEM, Direct Rx, ADVANCED RX PHARMACY OF TENNESSEE LLC, Proficient Rx LP. 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 Rozerem?
- 24 companies list ramelteon 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 ramelteon active ingredient?
- 8 companies list ramelteon as a bulk ingredient, including Zhejiang Ausun Pharmaceutical Co., Ltd., Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited, Biophore India Pharmaceuticals Private Limited.