Calcium-sensing Receptor Agonist
Where is Cinacalcet made?
15 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 15 factories in India and the United States.
India 11United States 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited30 mg, 60 mg, 90 mg · NDC 84386-111, 84386-112, 84386-113 | Appco Pharma LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Cipla USA., Inc.30 mg, 60 mg, 90 mg · NDC 69097-410, 69097-411, 69097-412 | Ascent Pharmaceuticals IncMakes it, tests it, packages it and labels it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Cipla LimitedMakes it, tests it, packages it and labels it | Raigad, India | Problems found, fixed voluntarilyApr 2024 | |
| Slate Run Pharmaceuticals, LLC.30 mg, 60 mg, 90 mg · NDC 70436-007, 70436-008, 70436-009 | Piramal Pharma LimitedMakes the active ingredient | Sangareddy, India | Problems found, fixed voluntarilyFeb 2026 |
| Piramal Pharma LimitedMakes it | Pithampur, India | No problems foundMay 2023 | |
| Accord Healthcare Inc.30 mg, 60 mg, 90 mg · NDC 16729-440, 16729-441, 16729-442 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals30 mg, 60 mg, 90 mg · NDC 65162-155, 65162-157, 65162-213 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Ascend Laboratories, LLC30 mg, 60 mg, 90 mg · NDC 67877-503, 67877-504, 67877-505 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Cadila Healthcare Limited30 mg, 60 mg, 90 mg · NDC 70771-1054, 70771-1055, 70771-1056 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.30 mg, 60 mg, 90 mg · NDC 31722-103, 31722-104, 31722-105 | Hetero Labs LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.30 mg, 60 mg, 90 mg · NDC 47335-379, 47335-380, 47335-600 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Dr. Reddy's Laboratories Inc.30 mg, 60 mg, 90 mg · NDC 43598-367, 43598-368, 43598-369 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Strides Pharma Science Limited30 mg, 60 mg, 90 mg · NDC 64380-883, 64380-884, 64380-885 | Strides Pharma Science LimitedMakes it, tests it and packages it | Puducherry, India | Problems found, fixed voluntarilyFeb 2023 |
| XLCare Pharmaceuticals, Inc.30 mg, 60 mg, 90 mg · NDC 72865-150, 72865-151, 72865-152 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.30 mg, 60 mg, 90 mg · NDC 70710-1000, 70710-1001, 70710-1002 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Amgen Inc Sensipar30 mg, 60 mg, 90 mg · NDC 55513-073, 55513-074, 55513-075 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Exelan Pharmaceuticals, Inc.30 mg, 60 mg, 90 mg · NDC 76282-674, 76282-675, 76282-676 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cinacalcet 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:
50090-7096 - American Health Packaging:
60687-516 - AvPAK:
50268-188 - Bryant Ranch Prepack:
71335-2761,63629-8763,63629-9608,72162-1843+8 - Carilion Materials Management:
68151-4740 - Major Pharmaceuticals:
0904-7502 - Physicians Total Care, Inc.:
54868-5616 - Remedyrepack Inc.:
70518-4615 - State of Florida DOH Central Pharmacy:
53808-0577,53808-0578
Recalls
- Oct 7, 2026 · Class II · Strides Pharma Inc
Failed dissolution specifications - Jun 29, 2026 · Class II · Cipla USA, Inc. · 3 recall notices
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Jun 4, 2026 · Class II · Amgen, Inc. · 3 recall notices
CGMP Deviations - Mar 16, 2026 · Class II · Cipla USA, Inc. · 3 recall notices
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Nov 14, 2025 · Class II · Cipla USA, Inc. · 3 recall notices
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Jul 9, 2025 · Class II · Strides Pharma, Inc.
Failed Dissolution Specifications. - Mar 7, 2025 · Class II · Slate Run Pharmaceuticals · 2 recall notices
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. - Oct 10, 2024 · Class II · Accord Healthcare, Inc. · 3 recall notices
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Oct 9, 2024 · Class II · Dr. Reddy's Laboratories, Inc. · 3 recall notices
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.