Bisphosphonate
Where is Zoledronic Acid made?
21 companies sell it under their own name. Their labels name 8 factories in India, Portugal and China.
India 6Portugal 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC4 mg per 5 mL, 5 mg per 100 mL · NDC 63323-961, 63323-966 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| USV Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Daman, India | Serious problems, FDA actionApr 2026 | |
| BluePoint Laboratories.4 mg per 5 mL, 5 mg per 100 mL · NDC 68001-610, 68001-611 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Dr.Reddy's Laboratories Ltd.4 mg per 5 mL, 5 mg per 100 mL · NDC 55111-685, 55111-688 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Gland Pharma Limited0.04 mg per 1 mL, 4 mg per 100 mL, 4 mg per 5 mL, 5 mg per 100 mL · NDC 68083-672, 68083-142, 68083-116 +3 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Accord Healthcare Inc.4 mg per 5 mL · NDC 16729-242 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Apotex Corp.4 mg per 5 mL · NDC 60505-6110 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| AuroMedics Pharma LLC4 mg per 5 mL, 5 mg per 100 mL · NDC 55150-266, 55150-283 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BPI Labs, LLC4 mg per 5 mL · NDC 54288-100, 54288-183 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Dr. Reddy's Laboratories Inc.4 mg per 100 mL, 4 mg per 5 mL, 5 mg per 100 mL · NDC 43598-255, 43598-330, 43598-233 +1 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 mg per 5 mL · NDC 23155-170 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc.4 mg per 5 mL · NDC 0143-9642 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Meitheal Pharmaceuticals Inc.5 mg per 100 mL · NDC 71288-806 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Northstar Rx LLC.4 mg per 5 mL · NDC 72603-198 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Westminster Pharmaceuticals, LLC4 mg per 5 mL · NDC 69367-190 | USV Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Daman, India | Serious problems, FDA actionApr 2026 |
| Akorn4 mg per 5 mL · NDC 17478-327 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.4 mg per 5 mL · NDC 83634-801 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.5 mg per 100 mL · NDC 72266-152 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC4 mg per 5 mL, 5 mg per 100 mL · NDC 67457-390, 67457-619, 67457-794 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Reclast5 mg per 100 mL · NDC 0078-0435 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals0.04 mg per 1 mL, 0.05 mg per 1 mL · NDC 25021-826, 25021-830 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Reclast5 mg per 100 mL · NDC 66758-155 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 23, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility: Leaking vials - Sep 12, 2018 · Class III · Dr. Reddy's Laboratories, Inc. · 2 recall notices
Failed Impurities/Degradation Specifications: OOS for unknown impurities. - Mar 3, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial - Mar 4, 2014 · Class II · Sagent Pharmaceuticals Inc
Lack of Assurance of Sterility; leaking of premix bags
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.