brand_name_justification.pdf

BRAND NAME OR EQUAL

JUSTIFICATION AND APPROVAL

Purchase Request No:

Department NAVY MEDICINE WEST

IA W FAR 13.106(1 )(b)

L Description of the supplies and/or services required to meet the end-user's minimum needs :

RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 µg), is a prescription medicine given by intramuscular injection that is used to prevent·Rh immunization, a condition in which an individual with RJ1-negative blood develops antibodies after exposure to Rh-positive blood. Rho(D) immune globulin is used to prevent Rh isoimmunization in mothers who are Rh negative and. to treat idiopathic thrombocytopenic pmpura (ITP) in people who are Rh positive. It is often given both during and following pregnancy. It may also be used when Rh negative people are given Rh positive blood.

2. Estimated value ofthe requirement:

3. Contractor's unique qualifications which make him/her the ONLY source that can truly satisfy the Government's 'minimum requirements:

Kedrion is a lea<;ling biophannaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. U.S. Food and Drug Administration has approved its application for the transfer of the Rhogam® aseptic filling, visual inspection, labelling/packaging and associated analytical testing from Ortho Clinical Diagnostics to its Melville plant This milestone. is an important step toward the Company eventually being in a position to produce RhoGAM® entirely from start to finish, using Kedrion Biopharma plasma. These brand name products are essential to the FDA's requirements and ANY other brand name RhoGani set carmotmeet the agency's need based on the rationale in block 1.

4. Demonstration of the market search conducted appropriate to the size and complexity of the Government's minimum requirements. Include sources (in Government and Industry) contacted and information obtained per source which further supports a sole source acquisition request.:

Performed an interuet search and found one other company that supplies the item, Commonwealth Serum Laboratories. Rhophylac is manufactured by CSL Limited. RhoGAM and MICRhoGam are brand names of Kedrion Biopharma.

5. Other facts supporting the use of other than full and open competition:

All standard operating procedures/configurations/administration settings existing are. set for hardware and software for the RhoGAM® · Ultra-Filteted PLUS [Rho(D) Immune Globulin (Human)] (300 µg), at this time. Changing that would seriously impact workload and · require extensive staff retraining, product validation, and multiple standard operating procedure updates.

6. Statement of the actions that are being taken to remove or overcome any barriers to competition:

None.

Signature of Director/Chau

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