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trū® Chitosan: Defining Medical-Grade Chitosan

trū Chitosan sets the global standard for medical-grade chitosan, offering unmatched purity, regulatory compliance, and traceability for pharmaceutical and medical device applications.

USP-NF Compliant: Meets or exceeds all the compendium’s identity, purity, and performance standards for pharmaceutical-grade chitosan.
USP-232 Impurity Limits: Exceeds global thresholds for elemental impurities across all drug delivery routes.
Manufactured Under cGMP: Produced using FDA-inspected current Good Manufacturing Practices ensuring consistent behavior and performance.
FDA Registered Facility: Fully registered and audited for medical application products.
Certificate of Analysis: Certified laboratory tested for identity, purity, and performance.
Certificate of Origin: Full vertical integration, including species traceability and tissue origin.
Single-Species Shrimp Source: Derived exclusively from edible shrimp exoskeletons, as defined by USP-NF.

trū Chitosan is more than compliant - it defines what medical-grade chitosan should be. From vertical integration to regulatory precision, we deliver chitosan trusted by pharmaceutical leaders worldwide. Whether for inhalant, injectable, oral, or topical applications, trū Chitosan ensures purity, performance, and peace of mind.

USP Inhalant Ultra

USP-NF & USP 232 Inhalant Conforming

≤ 2 EU/ml Endotoxin Content

cGMP

World’s Finest Medical Application Chitosan

USP Inhalant

USP-NF & USP 232 Inhalant Conforming

> 2 ≤ 10 EU/ml Endotoxin Content

cGMP

USP Parenteral Ultra

USP-NF & USP 232 Parenteral Conforming

≤ 2 EU/ml Endotoxin Content

cGMP

USP Parenteral

USP-NF & USP 232 Parenteral Conforming

> 2 ≤ 10 EU/ml Endotoxin Content

cGMP

GMP Parenteral Ultra

USP 232 Parenteral Conforming

≤ 2 EU/ml Endotoxin Content

cGMP

GMP Parenteral

USP 232 Parenteral Conforming

> 2 ≤ 10 EU/ml Endotoxin Content

cGMP

GMP Oral

USP 232 Oral Conforming

cGMP

trū Chitosan is available in a range of DDA from 70 % to 95% and GPC measured weight average molecular weight from 100-1600 kDa.

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325411 Medicinal and Botanical Manufacturing
325998 Chemical Manufacturing
541380 Testing Laboratories
541690 Scientific & Technical Consulting
541711 Research and Development in BioTech
541713 R&D Nanotechnology
541714 R&D Biotechnology
541990 All other Professional Scientific and Tech services
cGMP Compliance (CFR 21.211) - US Food & Drug Administration
ISO Compliance (ISO 9001) - US National Institutes of Health
Controlled Substance, All Schedules (RN: RP0615685) - US DEA

SC Compliance (SC 40-43-83) - South Carolina Board of Pharmacy
DHEC, All Schedules (RN: 95-19735) - South Carolina Board of Health & Environmental Control
Legal Name: Parimer Scientific, LLC
Federal Tax ID Number: 83-0963932
SC Tax ID Number: 115080642
DUNS Number: 038696069
Cage Code: 89SY8
FDA Registration Number: 3014735278
TTB Permit: MNBP-SC-21002
Medical Alcohol Permit: SDS-SC-2003

Our production partner

trū Chitosan works closely with Parimer Scientific for large-scale chitosan production and formulation of chitosan-related derivatives.

trū Chitosan

Chitolytic

Chitinor

HMC+

Primex

trū Chitosan

Endotoxins undetectable

trū Chitosan

Low in heavy metal

trū Chitosan

Custom formulations available

trū Chitosan

70–95% DDA

trū Chitosan

Single-source supply

trū Chitosan

Complete chain of custody

trū Chitosan

Certificate of Origin included

trū Chitosan

Certificate of Analysis included

trū Chitosan

FDA-registered facility

trū Chitosan

USP-NF conformance

trū Chitosan

NSF-certified production

trū Chitosan

ISO 9001 certification

trū Chitosan

Each product lot is tested by chitosan chemistry experts in a FDA-registered and ISO-accredited facility according to methods outlined by the United States Pharmacopeia (USP) that are specific to chitosan. The facility and its processes are audited multiple times each year to ensure ongoing compliance.
Yes! Chitosan HCL was added as an excipient to the European Pharmacopoeia 6.0 in 2002, followed by the United States (USP-NF 34) in 2012. Learn more.
Yes! Chitosan is stable in a wide range of conditions and is commonly mixed with other polysaccharides—including hydroxypropyl methylcellulose (HPMC), gelatin, collagen, peptides and hyaluronic acid. In general, chitosan will turn into a gel in both acids and solids when neutral or basic, but the molecule remains intact.
Yes. However, please note that trū Chitosan by itself is not a medical product and is not indicated by the FDA for any purpose other than as a raw material for use in medical products or as an excipient.
We are happy to work with you and create a wide range of form factors (gel, liquid, solid, powder, fiber, fleece, etc.). For more information, contact us

Contract Manufacturing

Powder Manufacturing

Liquid Manufacturing

Custom Packaging

Private Label Manufacturing
Lot Traceability

Change Control Management

Document Control

Label Generation, Control, and Reconciliation

Environmentally Monitored Production Processes

Environmentally Controlled Production Facilities and Warehouses

Non-Animal Origin (BSE/TSE) Control

Corrective Action/Preventative Action (CAPA) Systems

Supplier Management

Validated Manufacturing and Production Processes

Quality Monitored Production Processes

In-House Audit Program

Personnel Training Programs

Our distribution partner

trū Chitosan partners with Hawkins, Inc. for the bulk distribution of chitosan products across a national network of warehouses and branch facilities.

FREQUENTLY ASKED QUESTIONS

Let's talk chitosan.

Our experienced chitosan pros are here to provide detailed information and help assess your unique needs.

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AVAILABLE PRODUCTS

Select a product tile to view characteristics and download a spec sheet.