Company: MDCXW
Filing Date: 2025-05-30
Form Type: 424B4
Source: 0001062993-25-010548
Chunk: 99

Company: Medicus Pharma Ltd.
Filing Date: 2025-05-30
Form: 424B4
Chunk 99
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 the array samples by a validated HPLC method                                   |
| Needle strength/hardness                                                                                                        |     | Desiccation measured by loss on drying to approximately 5%.                                                                   |
| Dissolution of the microneedles sufficient to deliver the drug payload                                                          |     | Demonstrated in vitro, ex vivo, and in vivo.                                                                                  |
| Doxorubicin stability                                                                                                           |     | pH measurement of the solution prior to carboxymethyl cellulose ("CMC") addition; follow-up analytical testing for impurities |
| MNA = dissolvable microneedle array, HPLC = high power liquid chromatography, UV = ultra-violet, CMC = carboxymethyl cellulose. |     |                                                                                                                               |

Manufacturers of D-MNA Components

| API/Excipient   |     | Manufacturer/Lot Number                            |
| Doxorubicin HCl |     | Gemini PharmChem, Mannheim, GmbH, batch no. 070520 |

<div align='center'>62</div>

| API/Excipient                      |     | Manufacturer/Lot Number              |
| Citric acid anhydrous              |     | Fischer Scientific/185791            |
| Sodium phosphate dibasic anhydrous |     | Fischer Scientific/175060            |
| Trehalose dihydrate                |     | Pfanstiehl/37108A                    |
| Carboxymethyl cellulose            |     | Dow distr. By aic, Inc./F294F88017   
 Spectrum Chemical Mfg. Inc./ 2JA0070 |
| USP purified water                 |     | Millipore/F7PA35615                  |

Composition of the Drug Product

Each array contains 400 microneedles with a total tip volume of 9.6 µL which are evenly filled with 9.6 µL of doxorubicin gel of the following composition. The doses in the headline refer to the base of doxorubicin. The current formulation contains an overage of 5% of drug substance.

Controls of Critical Steps and Intermediates

The following are fundamental to the production of arrays according to GFE Protocol P171016-1-R3.

•Preparation:Assembly and gel formulation.

•Deposition 1 (Tip Loading):Deposition of the formulation containing active doxorubicin and excipients.

•Deposition 2 (Backing Plate):Deposition of formulation containing only excipients to create the backing plate to the needle