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Injectable and Dialysis Solutions and Speciality APIs

At Roquette, we understand that every dose counts. Pharmaceutical manufacturers around the world depend on our high-purity specialty active pharmaceutical ingredients (APIs), excipients, and osmotic agents to create injectable formulations and dialysis solutions that patients can trust. 

 

Injectable and Dialysis Solutions and Specialty APIs 

From life-saving large volume parenterals (LVP) to total parenteral nutrition (TPN) solutions, our ingredients are carefully produced to meet the most stringent microbial and biological standards. Each product reflects decades of expertise and a commitment to quality, safety, and regulatory compliance. 

Our expanded portfolio includes specialty APIs like Isosorbide C Pharma, bridging the gap between parenteral and oral administration and allowing formulators to explore new treatment possibilities with confidence. With Roquette, you can count on more than just ingredients. You gain a partner dedicated to helping you deliver effective, reliable therapies to patients. 

Solutions for Injectables, Dialysis Preparations, and Specialty APIs 

Developing safe and effective injectable and dialysis treatments requires more than just high-purity ingredients. It demands solutions that support both patient safety and manufacturing reliability. Roquette provides a comprehensive range of pyrogen-free APIs and excipients to meet the rigorous requirements of parenteral applications.  

LYCADEX® PF dextrose monohydrate pyrogen-free provides a stable, soluble carbohydrate source that is essential for large volume parenteral (LVP) and total parenteral nutrition (TPN) applications, while also serving as an osmotic agent for dialysis preparations. PEARLITOL® PF mannitol pyrogen-free can function both as an API and an excipient, supporting freeze-dried injectable formulations with its unique physical properties and protective effects on active ingredients. NEOSORB® PF sorbitol pyrogen-free contributes further flexibility as a pyrogen-free API suitable for parenteral applications. 

For formulations requiring precise ionic balance or pH regulation, Sodium Gluconate Pharma offers a highly purified organic salt tailored for injectable preparations and dialysis solutions. Meanwhile, KLEPTOSE® HPB, HP and HPB-LB hydroxypropyl beta-cyclodextrin are advanced parenteral-grade excipients that help solubilize and stabilize sensitive APIs while reducing potential irritation at the injection site.  

Our portfolio includes Isosorbide C Pharma, a specialty API for oral administration, allowing manufacturers to access versatile, high-quality ingredients while maintaining the same rigorous quality standards. 

Together, these ingredients reflect Roquette’s commitment to quality, consistency, and technical support, giving pharmaceutical manufacturers the confidence to formulate treatments that are both safe and effective for patients. 

Expert Support and Innovative Services for Pharmaceutical Manufacturers 

 

Our team of Health & Pharma Solutions experts supports pharmaceutical manufacturers with optimized and validated processes, comprehensive quality assurance, and dedicated regulatory support. Through our Customer Technical Services (CTS) laboratories, we provide technical services, formulation support, and testing capabilities alongside a vertically integrated, pyrogen-free range of APIs and excipients. The result is a seamless combination of quality, regulatory compliance, supply chain transparency, and traceability, helping you deliver safe and effective treatments while better serving your patients’ needs. 

Explore Our Pyrogen-Free Injectable and Dialysis Ingredients

Our pyrogen-free portfolio provides reliable pharmaceutical ingredients for injectable and dialysis formulations. Each product is manufactured to the highest standards, ensuring purity, consistency, and performance.

  • Isosorbide C Pharma

    A specialty API for oral administration that meets our high quality standards for APIs. It expands formulation options for manufacturers seeking versatile, high-quality pharmaceutical ingredients.

  • KLEPTOSE® HPB, HP and HPB-LB hydroxypropyl beta-cyclodextrin parenteral grade

    Parenteral-grade excipients for solubilizing and stabilizing APIs. They help reduce irritation at the injection site and maintain robust stability under sterilization and acidic conditions.

  • LYCADEX® PF dextrose monohydrate

    A pyrogen-free carbohydrate source widely used in parenteral preparations. It is highly soluble, stable, and well characterized, providing reliable performance for large volume parenteral (LVP), total parenteral nutrition (TPN), and osmotic agent for dialysis applications.

  • NEOSORB® PF sorbitol

    A pyrogen-free API suitable for parenteral applications, including irrigation fluids. It offers high solubility and stability, making it a reliable component in injectable formulations.

  • PEARLITOL® PF mannitol

    Serves both as an API and as an excipient for injectable formulations. Its unique physical and chemical properties support freeze-dried powders with aerated, porous structures and can help prevent oxidative degradation of active ingredients.

  • Sodium Gluconate Pharma

    A highly purified organic salt used in injectable preparations and dialysis solutions. It functions as a physiologically compatible electrolyte and pH regulation agent, ensuring reliable formulation performance.

Our Applications

Biologics

Stabilizers, cryoprotectants, and process aids for safe, efficient biologic formulation and manufacturing.

Injectables, Dialysis and APIs

High-purity excipients ensuring biocompatibility and isotonicity in parenteral and dialysis applications.

Oral Dosage Solutions

Functional excipients improving flow, compressibility, solubility, and taste for tablets and capsules.