Drug Shortage Report for OPTIMYXIN
| Report ID | 197307 |
| Drug Identification Number | 00701785 |
| Brand name | OPTIMYXIN |
| Common or Proper name | Gramicidin and Polymyxin B Sulfate Oto-Ophthalmic Solution |
| Company Name | EURO-PHARM INTERNATIONAL CANADA INC |
| Market Status | MARKETED |
| Active Ingredient(s) | GRAMICIDIN POLYMYXIN B |
| Strength(s) | 0.025MG 10000UNIT |
| Dosage form(s) | DROPS |
| Route of administration | OTIC OPHTHALMIC OTIC OPHTHALMIC |
| Packaging size | 10 mL |
| ATC code | S03AA |
| ATC description | ANTIINFECTIVES |
| Reason for shortage | Other (Please describe in comments) |
| Anticipated start date | 2021-12-31 |
| Actual start date | 2022-01-01 |
| Estimated end date | 2025-07-01 |
| Actual end date | |
| Shortage status | Actual shortage |
| Updated date | 2023-07-04 |
| Company comments | Reason for shortage: Transfer of manufacturing site. The new manufacturing site which was in process of approval by Health Canada from 2021 to 2022, has received FDA warning letter in 2022, which forced Euro-Pharm to look actively for new manufacturing sites. The estimated end date depends on approval timelines for the manufacturing site transfer. |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 9400 BOUL. LANGELIER MONTREAL, QUEBEC CANADA H1P 3H8 |
| Company contact information | Ali Khamessan |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v2 | 2023-07-04 | French | Compare |
| v1 | 2023-07-04 | English | Compare |
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