Vitamin D3 Analog
Where is Calcitriol made?
19 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 12 factories in the United States, India, China and Canada.
United States 6India 4China 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.25 ug, 0.5 ug, 1 ug per 1 mL · NDC 63304-239, 62756-967, 63304-240 +2 | Catalent Pharma SolutionsMakes it | Allendale, New Jersey, United States | No problems foundOct 2011 |
| Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 | |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 | |
| Bionpharma Inc.0.25 ug, 0.5 ug · NDC 69452-207, 69452-208 | Esjay Pharma Private LimitedMakes it | Kancheepuram, India | Not inspected on record |
| Patheon Softgels Inc.Makes it | High Point, NC, United States | Problems found, fixed voluntarilyJul 2025 | |
| Akorn1 ug per 1 mL, 2 ug per 1 mL · NDC 17478-931, 17478-831, 17478-932 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Amneal Pharmaceuticals0.25 ug, 0.5 ug · NDC 65162-519, 65162-576 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Epic Pharma, LLC0.25 ug, 0.5 ug · NDC 42806-732, 42806-733 | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdMakes it | Wuhan, China | Problems found, fixed voluntarilyMar 2025 |
| Fosun Pharma USA Inc.1 ug per 1 mL · NDC 72266-251 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Galderma Laboratories, L.P. Vectical3 ug per 1 g · NDC 0299-2012 | G Production IncMakes it | Baie D'Urfe, Canada | No problems foundFeb 2023 |
| Gland Pharma Limited1 ug per 1 mL · NDC 68083-316 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0.25 ug, 0.5 ug · NDC 23155-662, 23155-663 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc.0.25 ug, 1 ug per 1 mL · NDC 0054-0007, 0054-3120 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Padagis Israel Pharmaceuticals Ltd3 ug per 1 g · NDC 45802-608 | G Production IncMakes it | Baie D'Urfe, Canada | No problems foundFeb 2023 |
| Rising Pharma Holdings, Inc.1 ug per 1 mL · NDC 64980-447 | InvaTech Pharma Solutions LLCMakes it | East Brunswick, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Strides Pharma Science Limited0.25 ug, 0.5 ug · NDC 64380-723, 64380-724 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| ANI Pharmaceuticals, Inc.1 ug per 1 mL · NDC 70954-831 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.0.25 ug, 0.5 ug · NDC 62135-610, 62135-611 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.1 ug per 1 mL · NDC 0143-9728 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Patrin Pharma, Inc.1 ug per 1 mL · NDC 39328-042 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.25 ug, 0.5 ug · NDC 0093-7352, 0093-7353 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Validus Pharmaceuticals LLC Rocaltrol0.25 ug, 0.5 ug, 1 ug per 1 mL · NDC 30698-143, 30698-144, 30698-911 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Calcitriol 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:
50090-6711,50090-7470 - American Health Packaging:
60687-345 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-633,43353-034,71610-521,71610-468+1 - Atlantic Biologicals Corps.:
17856-0723,17856-3120 - Bryant Ranch Prepack:
63629-7323,63629-8741,63629-2445,72162-1031+4 - Cardinal Health 107, LLC:
55154-8186 - Carilion Materials Management:
68151-0088 - Dispensing Solutions Inc.:
66336-851 - Golden State Medical Supply, Inc.:
51407-169,51407-170 - PD-Rx Pharmaceuticals, Inc.:
72789-058 - Physicians Total Care, Inc.:
54868-4584,54868-4582,54868-6265 - Remedyrepack Inc.:
70518-4775
Recalls
- Jun 15, 2018 · Class III · Validus Pharmaceuticals, Inc. · 2 recall notices
Subpotency: lower than expected potency result was obtained at the 18 month stability time point. - May 1, 2014 · Class II · Boehringer Ingelheim Roxane Inc
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.