Amide Local Anesthetic
Where is Ropivacaine made?
19 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 12 factories in India, Germany, Austria, the United States, Norway, Portugal and 1 other.
India 6Germany 1Austria 1United States 1Norway 1Portugal 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC Naropin2 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 10 mg per 1 mL · NDC 63323-288, 63323-285, 63323-286 +1 | Fresenius Kabi AustriaMakes it, tests it and packages it | Austria 8055, Austria | Problems found, fixed voluntarilyMar 2024 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| HP Halden Pharma ASMakes it, tests it and packages it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 | |
| BioQ Pharma Incorporated2 mg per 1 mL · NDC 71807-011 | Pioneer Agro IndustriesMakes the active ingredient | Location not on file | Not inspected on record |
| Rommelag CDMO GmbHMakes it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 | |
| Akorn2 mg per 1 mL, 5 mg per 1 mL · NDC 17478-082, 17478-081 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Amneal Pharmaceuticals LLC2 mg per 1 mL, 5 mg per 1 mL · NDC 70121-1732, 70121-1733, 70121-1734 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Mehsana, India | Not inspected on record |
| AuroMedics Pharma LLC2 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 10 mg per 1 mL · NDC 55150-200, 55150-201, 55150-195 +4 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Baxter Healthcare Corporation2 mg per 1 mL, 5 mg per 1 mL, 10 mg per 1 mL · NDC 43066-027, 43066-152, 43066-154 +3 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Caplin Steriles Limited2 mg per 1 mL, 5 mg per 1 mL, 10 mg per 1 mL · NDC 65145-110, 65145-107, 65145-165 +3 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Fresenius Kabi USA, LLC2 mg per 1 mL · NDC 65219-632 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited2 mg per 1 mL · NDC 68083-262, 68083-263 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Glenmark Pharmaceuticals Inc., USA2 mg per 1 mL, 5 mg per 1 mL, 10 mg per 1 mL · NDC 68462-795, 68462-777, 68462-793 +2 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Hikma Pharmaceuticals USA Inc.2 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 10 mg per 1 mL · NDC 0143-9266, 0143-9195, 0143-9196 +4 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Meitheal Pharmaceuticals Inc.2 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 10 mg per 1 mL · NDC 71288-737, 71288-738, 71288-732 +4 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Somerset Therapeutics, LLC2 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 10 mg per 1 mL · NDC 70069-066, 70069-067, 70069-061 +4 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Anthea Pharma Private Limited2 mg per 1 mL, 5 mg per 1 mL, 10 mg per 1 mL · NDC 83854-015, 83854-013, 83854-014 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.150 mg per 30 mL · NDC 72485-519 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.5 mg per 1 mL · NDC 72572-707 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC2 mg per 1 mL · NDC 67457-798, 67457-799 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC2 mg per 1 mL · NDC 70512-797, 70512-798 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals2 mg per 1 mL, 5 mg per 1 mL · NDC 25021-671, 25021-652 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ropivacaine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
Recalls
- Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products - Apr 17, 2025 · Class I · Amneal Pharmaceuticals, LLC
Presence of Particulate Matter
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.