Pfanstiehl

What Pfanstiehl does

Pfanstiehl, Inc. is a privately held, Delaware-incorporated manufacturer of high-purity pharmaceutical excipients, headquartered in Waukegan, Illinois, with between 101 and 250 employees. Founded in 1919, the company has operated for over a century supplying injectable-grade raw materials to the biopharmaceutical and vaccine industries under the HPLE-LM (High Purity, Low Endotoxin, Low Metals) proprietary standard. All products are manufactured under full ICH-Q7 cGMP conditions in the United States and are compliant with multiple pharmacopoeia (USP, NF, EP, BP, JP, ChP, JPE), enabling global market access for customers.

The company's core product portfolio spans carbohydrate excipients (sucrose, trehalose, galactose, maltose, mannose, mannitol, glucose), amino acids (arginine, histidine, methionine, glycine, glutamine), buffer components (Tris Base, Tris HCl, sodium succinate, succinic acid), and sodium gluconate for Large Volume Parenterals. Beyond catalog excipients, Pfanstiehl offers Custom API Manufacturing and Custom ADC (Antibody-Drug Conjugate) Linker Manufacturing services, and markets formulation solutions targeting vaccine and biologic stabilization, protein aggregation reduction, viscosity reduction, low metals, low nitrosamines, inhalation biologics, and bispecific/trispecific antibody formulations.

Revenue is generated primarily through direct B2B sales to biopharmaceutical manufacturers, vaccine producers, and pharmaceutical formulation companies including CDMOs, with a complementary e-commerce storefront selling catalog products in standard package sizes (100g to 50kg) at unit prices ranging from roughly $60 to over $2,500 per SKU. Distribution is direct, with no disclosed intermediaries. The company is led by James A. Breckenridge as Chairman, CEO, and President. International reach is signaled by a nine-language website (English, German, French, Italian, Spanish, Portuguese, Japanese, Chinese, Korean) and active participation in industry conferences in India, the United States, and Europe.

Name

Pfanstiehl

Legal name

Pfanstiehl, Inc.

Website

https://pfanstiehl.com

Company type

Private

Founded year

1900

Operating status

Operating

Headcount range

101–250 employees

Short description

Pfanstiehl manufactures high-purity, low-endotoxin, low-metals (HPLE-LM) GMP injectable-grade excipients, including carbohydrates, amino acids, buffers, and sodium gluconate, for global biopharmaceutical and vaccine manufacturers. Founded in 1919 and based in Waukegan, Illinois, the company also offers custom API and ADC linker manufacturing services under multi-compendial compliance.

Ownership category

akta.pro rank

Product category

Pharmaceutical Excipients

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Industrial Organic Chemicals (2860)

akta.pro primary industry

Raw Materials & Critical Reagents Supply (Media/Resins/Cytokines) (HLAGAGAI)

akta.pro secondary industry

Compounding Ingredient & API Distributors (Pharma Supply) (HLAIAJAO)

Keywords

• Pharmaceutical excipients manufacturing
• GMP injectable grade excipients
• Biopharmaceutical raw materials
• High purity chemicals
• CGMP bioprocessing solutions

Headquarters

HQ city

Waukegan

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Personnel, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. GMP Injectable-Grade Excipients Sales: Pfanstiehl generates revenue through the sale of high-purity pharmaceutical excipients including carbohydrates (sucrose, trehalose, galactose, maltose, mannose, mannitol, glucose), amino acids (arginine, histidine, methionine, glycine, glutamine), buffer components (Tris Base, Tris HCl, sodium succinate, succinic acid), and sodium gluconate. Products are sold in various package sizes (100g, 1kg, 5kg, 10kg, 25kg, 50kg) directly to biopharmaceutical and vaccine manufacturers.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Pfanstiehl manufactures and sells high-purity, low-endotoxin, low-metals (HPLE-LM) cGMP injectable-grade pharmaceutical excipients for the biopharmaceutical industry. The portfolio includes carbohydrate excipients (sucrose, trehalose, mannitol, glucose), amino acids (arginine, histidine, glycine, glutamine), and buffer components (Tris Base, Tris HCl, sodium succinate, succinic acid), along with custom API and custom ADC linker manufacturing services.

Product overview

Pfanstiehl is a manufacturer of High Purity, Low Endotoxin, Low Metals (HPLE-LM) GMP Injectable Grade Excipients for the biopharmaceutical industry. The company has been in operation for over 100 years and manufactures pharmaceutical excipients under ICH-Q7 cGMP conditions in the United States. Their core product portfolio includes Carbohydrate Excipients (Sucrose, Trehalose dihydrate, D-Galactose, Maltose Monohydrate, D-Mannose, D-Mannitol, Glucose), Amino Acids (L-Arginine, L-Arginine HCl, L-Histidine, L-Histidine HCl, L-Methionine, Glycine, L-Glutamine, Arginine Glutamate), Buffer Components (Tris Base, Tris HCl, Sodium Succinate Hexahydrate, Succinic Acid), and Large Volume Parenterals (Sodium Gluconate). All products comply with multiple pharmacopoeia standards (USP, NF, EP, BP, JP, ChP, JPE) and are designed for vaccine and biologic stabilization, protein aggregation reduction, viscosity reduction, and other formulation challenges. The company also offers Custom API Manufacturing and Custom ADC Linker Manufacturing services.

Differentiator

Problem solved

Functional benefit

Brands

• HPLE-LM: High Purity Low Endotoxin Low Metals trademarked brand for injectable grade excipients

Products and services

• HPLE-LM GMP Injectable Grade Excipients Pfanstiehl's flagship product line consisting of pharmaceutical-grade excipients manufactured under ICH-Q7 cGMP conditions in the United States for injectable biologic and vaccine formulations.
• Carbohydrate Excipients Carbohydrate excipients including Sucrose, Trehalose dihydrate, D-Galactose, Maltose Monohydrate, D-Mannose, D-Mannitol, and Glucose (Dextrose) used as stabilizers, cryoprotectants, and bulking agents in biologic formulations.
• Amino Acid Excipients Amino acids including L-Arginine, L-Arginine HCl, L-Histidine, L-Histidine HCl, L-Methionine, Glycine, L-Glutamine, and Arginine Glutamate used for pH stabilization, protein stabilization, and viscosity reduction in biologic formulations.
• Buffer Components Buffer components including Tris Base, Tris HCl, Sodium Succinate Hexahydrate, and Succinic Acid used for pH buffering and stabilization in parenteral formulations.
• Sodium Gluconate USP High Purity, Low Endotoxin, Low Metals USP-grade sodium gluconate (CAS 527-07-1) used in Large Volume Parenterals as an electrolyte agent and buffering agent.
• Tris HCl High Purity, Low Endotoxin, Low Metals GMP grade Tris HCl buffering agent (CAS 1185-53-1) effective in the pH range of 7.2 to 9.0 for biologics manufacturing.
• Tris Base Multi-Compendial Tris Base (CAS 77-86-1) compliant with USP, EP, BP, and ChP pharmacopoeia, used as a zwitterionic amine buffer with pH stability between 7 and 9 in biologics production.
• Succinic Acid Multi-Compendial Succinic Acid (CAS 110-15-6) compliant with USP/NF, EP, BP, JP, and ChP pharmacopoeia, used as a dicarboxylic acid for pH buffering and protein stabilization in biologic formulations.
• Sodium Succinate Hexahydrate High Purity, Low Endotoxin, Low Metals Sodium Succinate Hexahydrate (CAS 6106-21-4) compliant with NF and JPE pharmacopoeia, used as a buffering agent, stabilizer, and solubility enhancer in pharmaceutical manufacturing.
• Custom API Manufacturing Custom Active Pharmaceutical Ingredient (API) manufacturing services for specialized pharmaceutical applications, leveraging the company's cGMP manufacturing capabilities.
• Custom ADC Linker Manufacturing Custom Antibody-Drug Conjugate (ADC) Linker manufacturing services for targeted therapeutic applications, supporting biologic drug developers with specialized linker chemistry production.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves2 records

Expansion highlights5 records

Direct peers

• DFE Pharma: DFE Pharma is a global supplier of high-quality excipients and functional ingredients for the pharmaceutical and biopharmaceutical industries, directly competing with Pfanstiehl in carbohydrate, amino acid, and buffer excipients used in solid dose and biologic formulations.
• JRS Pharma: JRS Pharma manufactures a wide range of excipients including binders, fillers, and specialty carbohydrates for pharmaceutical and biopharmaceutical applications, overlapping with Pfanstiehl's carbohydrate and buffer product lines.
• Roquette: Roquette is a global leader in starch, polyol, and pharmaceutical excipient manufacturing, with a strong biopharma excipient portfolio (e.g., trehalose, mannitol, cyclodextrins) that directly competes with Pfanstiehl's carbohydrate and specialty excipient offerings.
• Avantor: Avantor supplies high-purity chemicals, excipients, and raw materials to the biopharmaceutical and life sciences industries, with overlapping product lines in buffer components, carbohydrates, and amino acids for biologic manufacturing.
• Spectrum Chemical: Spectrum Chemical manufactures and distributes pharmaceutical-grade excipients, APIs, and buffer materials, serving as a direct catalog competitor to Pfanstiehl in excipients and compounding ingredients.

Broad incumbents

• MilliporeSigma (Merck KGaA Life Science): MilliporeSigma is the life science arm of Merck KGaA, offering a broad portfolio of bioprocessing raw materials, excipients, buffers, and process chemicals. It overlaps with Pfanstiehl across multiple excipient categories but operates at significantly greater scale and breadth.
• Thermo Fisher Scientific: Through its Pharma Services and life sciences chemicals businesses, Thermo Fisher supplies high-purity chemicals, excipients, and custom manufacturing services to biopharma customers, competing with Pfanstiehl as a broad incumbent rather than a specialty pure-play.
• Croda International: Croda's Pharma division supplies specialty excipients, including polysorbate alternatives and high-purity ingredients for injectable biologics, positioning it as a broad incumbent competitor to Pfanstiehl in biopharma formulation excipients.
• BASF Pharma Solutions: BASF's Pharma Solutions business offers a wide portfolio of excipients, APIs, and custom manufacturing services for the pharmaceutical industry, overlapping with Pfanstiehl across multiple excipient and custom manufacturing categories.
• Evonik Health Care: Evonik supplies specialty excipients, amino acids, and CDMO services to the pharmaceutical industry, with overlap to Pfanstiehl in amino acid excipients and custom manufacturing for complex molecules.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/pfanstiehl-inc-

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pfanstiehl