Kinase Inhibitor, mTOR Inhibitor Immunosuppressant
Where is Sirolimus made?
15 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 11 factories in India, the United States, Ireland and Japan.
India 6United States 3Ireland 1Japan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Mylan Pharmaceuticals Inc.0.5 mg, 1 mg, 1 mg per 1 mL, 2 mg · NDC 59762-1001, 59762-1002, 59762-1205 +1 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes it and tests it | Newbridge, Ireland | Problems found, fixed voluntarilySep 2022 |
| Wyeth Pharmaceutical Division of Wyeth Holdings LLCMakes the active ingredient and tests it | Pearl River, NY, United States | Problems found, fixed voluntarilyDec 2025 | |
| Northstar Rx LLC.0.5 mg, 1 mg, 1 mg per 1 mL, 2 mg · NDC 16714-187, 16714-188, 72603-409 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Amneal Pharmaceuticals1 mg per 1 mL · NDC 69238-1594 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 |
| Ascend Laboratories, LLC0.5 mg, 1 mg, 2 mg · NDC 67877-746, 67877-747, 67877-748 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Cadila Healthcare Limited0.5 mg, 1 mg, 2 mg · NDC 65841-771, 65841-772, 65841-773 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.1 mg per 1 mL · NDC 31722-316 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Dr.Reddy's Laboratories Ltd.1 mg, 2 mg · NDC 55111-653, 55111-654 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Glenmark Pharmaceuticals Inc., USA0.5 mg, 1 mg, 2 mg · NDC 68462-682, 68462-683, 68462-684 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Nobelpharma America, LLC Hyftor2 mg per 1 g · NDC 73683-101 | TOYO Pharmaceutical Co., Ltd.Makes it and tests it | Osaka, Japan | Problems found, fixed voluntarilyJun 2023 |
| Novadoz Pharmaceuticals LLC1 mg per 1 mL · NDC 72205-099 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Rising Pharma Holdings, Inc.1 mg per 1 mL · NDC 16571-806 | Cohance Lifesciences LimitedMakes it, tests it, packages it and labels it | Sangareddy, India | No problems foundFeb 2024 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg, 1 mg, 2 mg · NDC 68382-520, 68382-351, 68382-352 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Aadi Bioscience, Inc. Fyarro5 mg per 1 mL · NDC 80803-153 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.1 mg per 1 mL · NDC 60505-6197 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VistaPharm, LLC1 mg per 1 mL · NDC 66689-347 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Sirolimus 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.
- American Health Packaging:
60687-902,68084-915 - AvPAK:
50268-827,50268-718 - Bryant Ranch Prepack:
72162-2641 - Major Pharmaceuticals:
0904-7248 - Remedyrepack Inc.:
70518-3546,70518-4194,70518-4449,70518-4376+1
Recalls
- May 1, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications - Oct 13, 2022 · Class III · Aadi Bioscience
Failed Stability Specifications - May 3, 2022 · Class III · Apotex Corp.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. - May 12, 2021 · Class III · American Health Packaging
Failed Impurities/Degradation Specifications - Jun 3, 2016 · Class III · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.