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Update on CAPS Product Availability

 

Planned Neonatal Starter TPN, Cardioplegia, and Heparin Offerings

 

At Quva Pharma, we understand how important reliable medication supply is to your health system and the patients who depend on you. Following our acquisition of selected CAPS 503B portfolio assets, we are sharing advance information about products we plan to introduce so your teams can begin assessing clinical fit and anticipated demand.

Our immediate focus is six neonatal starter TPN formulations, four cardioplegia preparations and two Heparin products.We anticipate introducing the neonatal starter TPN and cardioplegia preparations first, followed by the Heparin products, with all planned offerings expected to be available in December 2026.

 

Neonatal starter TPN

The FDA recently issued temporary guidance concerning certain starter parenteral nutrition products for neonates. We are prioritizing six neonatal starter TPN formulations to help health systems prepare for potential supply challenges. Each formulation will be available in a refrigerated 250 mL bag with a 90-day beyond-use date.

 

Product Description

BUD

Amino Acids (TrophAmine) 3%, Dextrose 10%, Calcium Gluconate 3.75 mEq, Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

Amino Acids (TrophAmine) 4%, Dextrose 10%, Calcium Gluconate 3.75 mEq, Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

Amino Acids (TrophAmine) 3.5%, Dextrose 10%, Calcium Gluconate 2.33 mEq, Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

Amino Acids (TrophAmine) 3%, Dextrose 10%, Calcium Gluconate 2.33 mEq and Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

Amino Acids (TrophAmine) 3%, Dextrose 5%, Calcium Gluconate 3.75 mEq, Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

Amino Acids (TrophAmine) 3.5%, Dextrose 10%, Heparin Sodium 125 Units, 250 mL fill, 250 mL Bag

90 Days

 

Cardioplegia preparations

Quva Pharma plans to introduce four preservative-free cardioplegia preparations: two induction and two maintenancepreparations using CP2D or Plasma-Lyte A base solutions, each with a 45-day refrigerated beyond-use date.

 

Product Description

BUD

Cardioplegia Induction 4:1 High K (36 mEq) Low Tromethamine, CP2D, 500 mL fill, 500 mL Bag (PF)

45 Days

Cardioplegia Maintenance 4:1 Low K (36 mEq), Low Tromethamine, CP2D, 1000 mL fill, 1000 mL Bag (PF)

45 Days

Cardioplegia Induction 4:1 High K (50 mEq), Plasma-Lyte A, Tromethamine, 500 mL fill, 500 mL Bag (PF)

45 Days

Cardioplegia Maintenance 4:1 Low K (40 mEq), Plasma-Lyte A, Tromethamine, 1000 mL fill, 1000 mL Bag (PF)

45 Days

 

Heparin preparations

Following the neonatal starter TPN and cardioplegia introductions, Quva Pharma plans to add two Heparin preparations with 90-day beyond-use dates.

 

Product Description

BUD

Heparin Sodium 4000 Units (4 units/mL) in 1000 mL 0.9% Sodium Chloride Solution, 1000 mL Bag

90 Days

Heparin Sodium 5000 Units (10 units/mL) in 500 mL 0.9% Sodium Chloride Solution, 500 mL Bag

90 Days

 

Product availability, ordering dates and commercial details are still being finalized. We will share confirmed product numbers, quantities, pricing, contracting terms and ordering instructions as they become available.

Your Quva Pharma representative can discuss the planned products and work with you to understand anticipated needsby product and facility. We value the opportunity to plan with you as these offerings take shape. Thank you for the trust you place in Quva Pharma. Please contact your Quva Pharma representative with questions or to discuss your organization’s needs.

 

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