Drug
Who makes ropivacaine hydrochloride?
19 companies list ropivacaine hydrochloride as a human prescription drug, including under the names Naropin. Forms: injection; injection, solution. Routes: epidural, infiltration, perineural.
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 ropivacaine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection; injection, solution | ANDAANDA211907, ANDA214074 | 7 | 4 |
| Somerset Therapeutics Private LimitedIndia | injection | ANDAANDA207636 | 7 | 1 |
| Eugia US LLC | injection, solution | ANDAANDA205612 | 7 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA218713 | 7 | 0 |
| Baxter Healthcare CorporationUnited States | injection; injection, solution | ANDAANDA210102, ANDA212808 | 6 | 16 |
| CAPLIN STERILES LIMITEDIndia | injection | ANDAANDA212808 | 6 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection, solution | ANDAANDA219883 | 5 | 9 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDA, NDAANDA212808, NDA020533 | 5 | 6 |
| Amneal Ireland LimitedIreland | injection | ANDAANDA216605 | 4 | 1 |
| Anthea Pharma Private Limited | injection, solution | ANDAANDA219883 | 3 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA210102 | 2 | 4 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA206091 | 2 | 0 |
| SOLA Pharmaceuticals, LLC | injection, solution | ANDAANDA212808 | 2 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA206166 | 2 | 0 |
| Sportpharm LLC | injection; injection, solution | ANDAANDA205612, ANDA207636 | 2 | 0 |
| ProPharma Distribution, LLC.United States | injection | ANDAANDA207636 | 1 | 3 |
| Civica, Inc. dba CivicaRxUnited States | injection | ANDAANDA212808 | 1 | 1 |
| Henry Schein, Inc.United States | injection, solution | NDANDA020533 | 1 | 1 |
| Armas Pharmaceuticals, Inc. | injection | ANDAANDA212808 | 1 | 0 |
Bulk ingredient listings
- Excella GmbH & Co. KGGermany · 2 NDC
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Apex Healthcare LimitedIndia · 1 NDC
- Asence Pharma Private LimitedIndia · 1 NDC
- DISHMAN CARBOGEN AMCIS LIMITEDIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Fine Chemicals Corporation (PTY) Ltd.South Africa · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Shandong Anhong Pharmaceutical Co., Ltd.China · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
1 unexpired patent lists ropivacaine hydrochloride as the active ingredient, expiring between Nov 2026 and Nov 2026. Application holder: FRESENIUS KABI USA LLC.
Enquiry
Common questions
- Who makes ropivacaine hydrochloride?
- 19 companies list ropivacaine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Somerset Therapeutics Private Limited, Eugia US LLC, Meitheal Pharmaceuticals, Inc., Baxter Healthcare Corporation. 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 Naropin?
- 18 companies list ropivacaine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies ropivacaine hydrochloride active ingredient?
- 10 companies list ropivacaine hydrochloride as a bulk ingredient, including Excella GmbH & Co. KG, APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Apex Healthcare Limited, Asence Pharma Private Limited.