Platelet Aggregation Inhibitor
Where is Eptifibatide made?
10 companies sell it under their own name. Their labels name 6 factories in China, India and the United States.
China 3India 2United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AuroMedics Pharma LLC20 mg per 10 mL, 75 mg per 100 mL, 200 mg per 100 mL · NDC 55150-219, 55150-220, 55150-218 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Baxter Healthcare Corporation75 mg per 100 mL · NDC 0338-9558 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Round Lake, IL, United States | Serious problems, FDA actionApr 2026 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd.0.75 mg per 1 mL, 2 mg per 1 mL · NDC 52958-040, 52958-402 | Hainan Shuangcheng Pharmaceuticals Co., Ltd.Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Haikou City, China | Problems found, fixed voluntarilyJan 2024 |
| Meitheal Pharmaceuticals Inc.0.75 mg per 1 mL, 2 mg per 1 mL · NDC 71288-413, 71288-412 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Slate Run Pharmaceuticals, LLC.0.75 mg per 1 mL, 2 mg per 1 mL · NDC 70436-163, 70436-027, 70436-162 +1 | Hainan Poly Pharm. Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| USV Private Limited0.75 mg per 1 mL, 2 mg per 1 mL · NDC 62147-0601, 62147-0602 | Gland Pharma LimitedMakes it, tests it, packages it, labels it and sterilizes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Avenacy Inc.0.75 mg per 1 mL, 2 mg per 1 mL · NDC 83634-301, 83634-300 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hainan Poly Pharm. Co., Ltd.0.75 mg per 1 mL, 2 mg per 1 mL · NDC 14335-071, 14335-070 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC0.75 mg per 1 mL, 2 mg per 1 mL · NDC 67457-631, 72078-026, 67457-629 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals0.75 mg per 1 mL, 2 mg per 1 mL · NDC 25021-408, 25021-409 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Feb 12, 2026 · Class III · Slate Run Pharmaceuticals
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. - May 22, 2024 · Class III · Eugia US LLC
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.