Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biocon Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilySep 27, 2024 · 3 inspections |
| Biocon Pharma Limited | Bengaluru, India | Makes it, tests it and packages it | No problems foundJun 2, 2023 · 1 inspection |
Recalls
- Jan 31, 2023 · Class II · Biocon Pharma Inc
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Lots: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Posaconazole: every company that makes it
- Form
- tablet, delayed release, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA214476
- On the market since
- Mar 8, 2022
- Package NDCs
70377-038-11- Official label
- DailyMed (National Library of Medicine), updated May 6, 2026
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