NDC 70436-008
cinacalcet hydrochloride 60 mg tablet, film coated
On the label: Slate Run Pharmaceuticals, LLC..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Piramal Pharma Limited | Sangareddy, India | Makes the active ingredient | Problems found, fixed voluntarilyFeb 13, 2026 · 6 inspections |
| Piramal Pharma Limited | Pithampur, India | Makes it | No problems foundMay 19, 2023 · 8 inspections |
Recalls
- Mar 7, 2025 · Class II · Slate Run Pharmaceuticals
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Lots: Lot # 109797, Exp 11/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cinacalcet: every company that makes it
- Form
- tablet, film coated
- Strength
- 60 mg
- Approval
- ANDA ANDA210207
- On the market since
- Mar 6, 2019
- Package NDCs
70436-008-04- Official label
- DailyMed (National Library of Medicine), updated May 24, 2024
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