P2Y12 Platelet Inhibitor
Where is Prasugrel made?
10 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 6 factories in India and Germany.
India 5Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.5 mg, 10 mg · NDC 16729-273, 16729-272 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals5 mg, 10 mg · NDC 65162-002, 65162-001 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Apotex Corp.5 mg, 10 mg · NDC 60505-4643, 60505-4856, 60505-4642 | Panacea Biotec Pharma LimitedMakes it | Solan, India | Serious problems, FDA actionOct 2023 |
| Aurobindo Pharma Limited5 mg, 10 mg · NDC 65862-830, 65862-829 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cosette Pharmaceuticals, Inc. Effient5 mg, 10 mg · NDC 0713-0882, 0713-0881 | Daiichi Sankyo Europe GmbHMakes it and tests it | Pfaffenhofen a.d.Ilm, Germany | Problems found, fixed voluntarilyJul 2025 |
| Lupin Pharmaceuticals, Inc.5 mg, 10 mg · NDC 68180-796, 68180-795 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Panacea Biotec Limited5 mg, 10 mg · NDC 43817-240, 43817-239 | Panacea Biotec Pharma LimitedMakes it | Solan, India | Serious problems, FDA actionOct 2023 |
| Ascend Laboratories, LLC5 mg, 10 mg · NDC 67877-605, 67877-604 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.5 mg, 10 mg · NDC 0378-5186, 0378-5185 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.5 mg, 10 mg · NDC 29300-302, 29300-301 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Prasugrel 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.
- A-S Medication Solutions:
50090-5169 - American Health Packaging:
60687-883 - Bryant Ranch Prepack:
63629-4829 - Golden State Medical Supply, Inc.:
51407-445,51407-444 - Liberty Pharmaceuticals, Inc.:
0440-0605,0440-0604 - Physicians Total Care, Inc.:
54868-6238
Recalls
- Aug 21, 2026 · Class II · Golden State Medical Supply Inc.
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution - Aug 17, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria - Mar 5, 2025 · Class II · Golden State Medical Supply Inc.
Failed Dissolution Specifications - Feb 25, 2025 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications - low dissolution results - Oct 18, 2019 · Class II · Mylan Pharmaceuticals Inc.
Failed Dissolution Specification: Low out of specification dissolution results.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.