Drug
Who makes paroxetine hydrochloride hemihydrate?
11 companies list paroxetine hydrochloride hemihydrate as a human prescription drug. 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 paroxetine hydrochloride hemihydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA203854 | 6 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078902, ANDA203854 | 4 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA078902 | 4 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA078902 | 4 | 0 |
| Solco healthcare U.S., LLC | tablet, film coated | ANDAANDA203854 | 4 | 0 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA203854 | 3 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA203854 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078902, ANDA203854 | 2 | 1 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA203854 | 1 | 3 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA203854 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA203854 | 1 | 1 |
Bulk ingredient listings
- AX Pharmaceutical CorpCanada · 1 NDC
- Cutyx Research LLPIndia · 1 NDC
- MAEDA INCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Medichem SASpain · 1 NDC
- Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.China · 1 NDC
- Signa S.A. de C.V.Mexico · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Wanbury LimitedIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes paroxetine hydrochloride hemihydrate?
- 11 companies list paroxetine hydrochloride hemihydrate as a human prescription drug in the openFDA NDC Directory, led by RemedyRepack, Inc, PD-Rx Pharmaceuticals Inc., Aphena Pharma Solutions - Tennessee, LLC, Mylan Pharmaceuticals, Inc., Solco healthcare U.S., 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 paroxetine hydrochloride hemihydrate?
- 11 companies list paroxetine hydrochloride hemihydrate 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 paroxetine hydrochloride hemihydrate active ingredient?
- 11 companies list paroxetine hydrochloride hemihydrate as a bulk ingredient, including AX Pharmaceutical Corp, Cutyx Research LLP, MAEDA INC, MEDISCA Inc..