Notice of Intent to Sole Source: Synthesis of Lamivudine or Emtricitabine 4'- Thiohepatanoic Acid and Synthesis of Lamivudine 5-Aminoheptanic

The Centers for Disease Control and Prevention intends to award a SOLE SOURCE JUSTIFICATION for firm fixed price purchase order to Raybow Pharmaceuticals.

We propose a service contract with Raybow Pharmaceuticals. Raybow Pharmaceuticals will be responsible for the Synthesis of Lamivudine or Emtricitabine 4'- Thiohepatanoic Acid and Synthesis of Lamivudine 5-Aminoheptanic.

TargetPurity: Greater than or equal to 95% by HPLC

Target Quantity: 100 mg

Raybow Pharmaceuticals previously provided several similar chemical constructs. Due to the success of the prior purchased products and the company’s familiarity with the synthesis procedure for these unique and proprietary molecules, Raybow is the source for these products which are similar constructs of the previously purchased items.  Having these similar products from the same source/Raybow will allow the program to continue developing the assays seamlessly using the same methods. Raybow will provide continuity in the synthesized product that would be comparable to prior extensive work using the previous antiretroviral-heptanoic acid molecules. Having a different company will result in significant delays and waste of resources as it would requiren to start over and the methods would not perform similarly due to potential differences in the synthesis process.

Raybow is the only vendor that can provide the antiviral compounds using the consistent synthesis processes.

This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of 6.302-1 and 10 U.S.C. 3406. Interested persons may identify their interest and capability to respond to the requirement or submit proposals.

This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to contract specialist at cbp0@cdc.gov by COB 18 July, 2023.