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High-Purity, Low-Endotoxin Carbohydrates, Parenteral Grade Excipients and Highly Potent APIs

Pfanstiehl is a leading current good manufacturing practice (cGMP) manufacturer of parenteral grade excipients and highly potent APIs.

 

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1219 Glen Rock Avenue,
Waukegan, IL,
60085-0439,
United States of America
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Located in Waukegan, Illinois, Pfanstiehl is a leading current good manufacturing practice (cGMP) manufacturer specialising in parenteral-grade excipients and highly potent active pharmaceutical ingredients (API). With over 100 years of experience, Pfanstiehl plays a vital role in supplying High-Purity, Low-Endotoxin, Low Metals (HPLE-LM™) carbohydrates and amino acids to the pharmaceutical industry

High-purity, low-endotoxin carbohydrates

  • Trehalose
  • Sucrose
  • Galactose
  • Mannitol
  • Maltose
  • Mannose

High-purity, low-endotoxin amino acids

Pfanstiehl is a leading cGMP manufacturer of parenteral grade excipients and highly potent APIs.
Pfanstiehl’s manufacturing and development occur at its 13-building campus located near Chicago, Illinois, US.
The analytical services laboratory is equipped with modern analytical testing instrumentation.
With over 40 years of cGMP manufacturing experience, Pfanstiehl has prepared the necessary documentation, validation and qualification systems to ensure compliance with the FDA and other regulatory bodies worldwide.
  • L-Arginine
  • L-Arginine HCL
  • L-Histitidine
  • L-Histidine HCL
  • L-Methionine
  • L-Glutamine

Many of these carbohydrates are essential for the stabilisation of proteins, monoclonal antibodies (mAbs), and vaccines, making them a crucial component in injectable medications. Pfanstiehl collaborates with top pharmaceutical and biopharmaceutical companies around the globe, producing proprietary and commercial compounds in quantities ranging from grams to tonnes.

Customised manufacturing solutions

Whether you are developing a novel formulation as an innovator or replicating an existing one as a biosimilar firm, Pfanstiehl provides a reliable, high-purity solution. They specialise in custom synthesis of new chemical entities (NCEs), speciality carbohydrates, and injectable-grade cGMP pharmaceutical ingredients in commercial quantities. Pfanstiehl’s capabilities include process scale-up, development, and validation according to strict cGMP guidelines.

The company’s facilities are equipped to handle the production of HPLE compounds, including highly potent drugs, under cGMP conditions. Pfanstiehl also offers invaluable support in managing the regulatory process, establishing and maintaining both US and European Drug Master Files (DMFs) and European Certificates of Suitability, ensuring that your product is market-ready.

cGMP expertise and compliance

Pfanstiehl’s FDA-registered and inspected facilities are designed to meet the highest regulatory standards. With more than 15 active DMFs across the US, Canada and Europe, their cGMP manufacturing processes ensure the highest quality standards. The company’s fully qualified equipment and utilities in their cGMP manufacturing areas guarantee compliance, backed by robust validation and qualification systems.

As a trusted manufacturer of low-endotoxin carbohydrates, injectable-grade excipients, APIs, and pharmaceutical intermediates, Pfanstiehl is committed to helping its partners seamlessly bridge the critical gap between product development and regulatory approval, offering end-to-end solutions that ensure your compounds reach the market with confidence.

Quality, purity and safety in everything we do

Pfanstiehl’s extensive experience, combined with its state-of-the-art cGMP facilities and regulatory expertise, makes it a preferred partner for pharmaceutical firms worldwide. From custom synthesis to regulatory support, Pfanstiehl is dedicated to delivering high-purity, injectable-quality solutions that meet the most stringent industry standards.

White Papers

Videos

  • Pfanstiehl Tradeshow Video

    Vice-president of research and development (R&D) Dr. Trevor Calkins discusses Pfanstiehl’s active pharmaceutical ingredients (API) contract development and manufacturing organisation (CDMO) philosophy and capabilities at the CPhI/InformEx.

Press Releases

Products & services

  • Trehalose

    Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond.

  • Sucrose

    Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose, found in many plants but extracted as ordinary sugar mainly from sugar cane and sugar beets.

  • Galactose (NAD)

    Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides.

  • Buffer Components cGMP HPLE-LM™ by Pfanstiehl

    Buffer solutions are used in the pharmaceutical industry to maintain the pH value of drug compounds, ensuring their stability, solubility and biological activity while improving the purity of certain components. Pfanstiehl’s range of buffer components includes TRIS Base, TRIS HCl, Sodium Succinate Hexahydrate and Succinic Acid.

  • Custom API Manufacturing Services by Pfanstiehl

    Pfanstiehl has established a long and successful track record in custom-manufacturing active pharmaceutical ingredients (APIs) to meet our clients’ unique needs. Our company’s history is rich in innovation and excellence, built on decades of experience in the pharmaceutical industry.

  • Amino Acids cGMP Excipients HPLE-LM™ by Pfanstiehl

    Amino acids play a vital role in pharmaceutical development due to their matrix formulation, solubility, stability, modulation and biocompatibility. Pfanstiehl’s range of amino acids consists of L-Arginine, L-Histidine, L-Methionine and L-Glutamine, as well as hydrochloride (HCL) versions of L-Arginine and L-Histidine.

  • Carbohydrate Excipients cGMP HPLE-LM™ by Pfanstiehl

    Carbohydrate excipients have found much use in oral pharmaceutical formulations, being used to fulfil roles such as fillers, binders, thickeners, suspending agents, disintegrants and flavouring agents. Pfanstiehl provides a range of six carbohydrate excipients for use in pharmaceutical projects: sucrose, trehalose, D-Galactose, maltose, mannose and D-Mannitol.

Address
Pfanstiehl, Inc.
1219 Glen Rock Avenue
Waukegan, IL
60085-0439
United States of America

Email address
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