Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 115

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 115
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hl/37108A                                  |
| 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.

#### Demolding, Cutting, Desiccation, and Storage
Critical to quality parameters include:

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CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD.PURSUANT TO 17 C.F.R. SECTION 200.83</div>

In-Process Controls: D-MNA; P-MNA

| In-Process Controls (Engineering)                          |     | Limit                                                                                                                                                                                                                                                                                               |
| Master mold fabrication via milling process                |     | CAD/CAM of all suitable material rendering required geometry for microneedles                                                                                                                                                                                                                       |
| Production molds fabricated from polydimethyl siloxane     |     | Spun in the same centrifuge to fabricate the arrays such that forces and angles used to make production mold mirror those used to fabricate the arrays. Production molds inspected after every production cycle to ensure integrity of the needle forms-Protocol P171016-1 R3 governs this process. |
| Fabrication of each fixture necessary for array production |     | Protocol P171016-1 R3 provides these parameters                                                                                                                                                                                                                                                     |

| In-Process Controls (Formulation)               
 Dissolution of all materials in gel formulation |     | Limit                                                                                                                                                                         
 Visual inspection                                                                                                                                                             |
| Viscosity of the gel                            |     | Verified by cone plate viscometer torque reading; Brookefield Viscometer DVII+ calibrated at every run                                                                        |
| pH of the gel                                   |     | A pH of between 4.5 and 5.1 is sufficiently acidic. Follow procedure for dilution of gel, use of pH probe, and calculation (Determination of the pH of SkinJect Formulations) |

| In-Process Controls (Array Fabrication) |     | Limit                                                                                                             |
| Deposition and centrifugation.          |     | Deposit approximately