Drug
Who makes lurasidone hydrochloride?
27 companies list lurasidone hydrochloride as a human prescription drug, including under the names Latuda. Forms: tablet; tablet, coated; 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 lurasidone hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA213248 | 10 | 7 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA208037, ANDA212244 | 10 | 0 |
| Torrent Pharma, Inc.India | tablet, film coated | ANDAANDA208047, ANDA208055 | 6 | 5 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA208031, ANDA208047, ANDA212244 | 6 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet, coated | ANDAANDA208002 | 5 | 14 |
| Lupin LimitedIndia | tablet | ANDAANDA208031 | 5 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA208066 | 5 | 13 |
| Zydus Lifesciences LimitedIndia | tablet, coated | ANDAANDA208052 | 5 | 12 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet, film coated | ANDAANDA208028 | 5 | 7 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA212124 | 5 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA208049 | 5 | 2 |
| Sumitomo Pharma Co., Ltd.Japan | tablet, film coated | NDANDA200603 | 5 | 2 |
| Amneal Ireland LimitedIreland | tablet, coated | ANDAANDA208002 | 5 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA218174 | 5 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA208058 | 5 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA208058 | 5 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, coated | ANDAANDA208052 | 5 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA212244 | 5 | 0 |
| Dr. Reddys Laboratories Limited | tablet, film coated | ANDAANDA208047, ANDA208055 | 5 | 0 |
| Exelan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA208028 | 5 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA208037 | 5 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA212244 | 4 | 5 |
| NorthStar RxLLC | tablet, film coated | ANDAANDA212124 | 4 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA208045 | 3 | 6 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA208049, ANDA212091, ANDA212244 | 3 | 3 |
| Coupler LLCUnited States | tablet; tablet, film coated | ANDAANDA208045, ANDA213248 | 3 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA208045 | 1 | 1 |
Bulk ingredient listings
- PROCOS SpAItaly · 2 NDC
- Alivus Life Sciences Limited · 1 NDC
- Anonima Materie Sintetiche and Affini (AMSA) SpA · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Edmond Pharma S.r.lItaly · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Hisun Pharmaceutical (Nantong) Co., Ltd. · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Pharmachem Private LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Sumitomo Chemical Company, LimitedJapan · 1 NDC
- Sumitomo Pharma Co., Ltd.Japan · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
Orange Book patents
6 unexpired patents list lurasidone hydrochloride as the active ingredient, expiring between Nov 2026 and Nov 2031. Application holder: SUNOVION PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes lurasidone hydrochloride?
- 27 companies list lurasidone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, MAJOR Pharmaceuticals Inc., Torrent Pharma, Inc., RemedyRepack, Inc, Amneal Pharmaceuticals of New York, 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 Latuda?
- 26 companies list lurasidone hydrochloride 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 lurasidone hydrochloride active ingredient?
- 18 companies list lurasidone hydrochloride as a bulk ingredient, including PROCOS SpA, Alivus Life Sciences Limited, Anonima Materie Sintetiche and Affini (AMSA) SpA, Biocon Biologics Limited.