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Xttrium Laboratories, Inc. Mt. Prospect HLPC Equipment Xttrium Labs Facilities Xttrium Business Profile

 



Since its founding in 1932, Xttrium Laboratories has been family owned and operated. In a world where health and safety are primary concerns, Xttrium is proud to be providing solutions.

Xttrium is the largest U.S. supplier of FDA-approved 2 and 4% chlorhexidine gluconate (CHG) formulations, the most effective known antimicrobial for surgical scrubbing and health care personnel hand washing. Xttrium is also the leading U.S. manufacturer of 20% USP Chlorhexidine Gluconate, an antimicrobial agent.

We have over four decades of experience in producing FDA-approved and EPA-registered products. Xttrium is an established contracted manufacturer of CHG solutions and the owner of multiple NDA’s for topical antimicrobial surgical scrub solutions as well as the owner of an ANDA for 0.12% CHG oral rinse solution.

Xttrium has a long-standing and solid reputation as a leading supplier of antiseptics to hospitals and doctors. Our Analytical and Quality Control services will consistently meet or exceed clients’ expectations while providing professional courtesy and dependable customer care.

Xttrium is committed to developing new drugs, NDA's, and providing high quality on-time services, in order to ensure customer satisfaction.

Here at Xttrium we have built our name on quality.


Since its founding in 1932, Xttrium Laboratories has been committed to the protection of human health and well-being. Our excellent products prove that commitment.

Xttrium has long had a solid reputation as a leading supplier of antiseptics to hospitals and doctors. Now our superior products are available in pharmacies across the country.

We have over four decades of experience in producing FDA-approved and EPA-registered healthcare products.

In a world where health and safety are primary concerns, Xttrium is proud to be providing solutions.

Xttrium is the largest U.S. supplier of FDA-approved 2 and 4% CHG formulations, the most effective known antimicrobial for surgical scrubbing and health care personnel hand washing.

Xttrium is also the leading U.S. manufacturer of 20% USP Chlorhexidine Gluconate, an antimicrobial agent.


Xttrium’s Mount Prospect facilities are FDA registered and compliant with cGMPs.

Xttrium’s new 106,000 sq. foot Mt. Prospect facility combines temperature and monitored warehousing of finished product and raw materials, a new manufacturing and packaging area, and a fully qualified Quality Control Laboratory.

Xttrium's QC Lab is a fully qualified analytical chemistry laboratory with state of the art high performance liquid chromatography and gas chromatography instrumentation to perform raw material, in-process, and finished product chemistry release testing.

Xttrium maintains a complete quality system including OOS investigations, corrective action/preventive action, change control, validation (Equipment/Process/Packaging/Cleaning), internal and supplier audit programs and controlled document management system including access-controlled document room.


Both of Xttrium's facilites have fully qualified humidity and temperature controlled stability chambers for long and short term stability studies in accordance with ICH guidelines.

Xttrium strives to be a leader in health, safety and environmental performance, while developing new strategies, standards and systems for continuous improvement.


PRIVATE LABELING CAPABILITIES

Xttrium Laboratories has been an established Contracted Manufacturer of Chlorhexidine Gluconate (CHG) 2% and 4% Solutions since 1984. Owner of multiple NDA’s for these topical antimicrobial surgical scrub solutions, Xttrium has received FDA “Market Approval’ for their intended uses: Professional Handwash, Personal Handwash, Wound Cleansing, and Pre-Operative Surgical Site Preparation.

The Company processes the U.S. regulated and GMP compliant manufacturing capabilities to produce finished product in multiple container closures and closure systems. Recognized as “Industry Leader” in this important and very contemporary Infection Control category, Xttrium continues to innovate and build contract manufacturing partnerships with many of the recognized Brands and market leaders in the US Healthcare Industry.

Xttrium has grown with the industry and increased its formulations, production, and contract manufacturing capabilities of 2% and 4% CHG solutions.

 

RETAIL PRODUCTS: XTTRIUM BRAND ORAL RINSE & 4% CHG ANTISEPTIC CLEANSER

In 1999, Xttrium Laboratories gained FDA approval for its first CHG-based ANDA -- Xttrium Brand Generic Rx 0.12% Chlorhexidine Gluconate Oral Rinse. Today, 70% of national and regional drug, grocery, mass merchandisers and drug wholesaler independent pharmacies dispense Xttrium Brand Generic CHG Oral Rinse. Xttrium has grown this business nationally over the past 12 years and is currently looking to expand its reach into the generic Rx market using the success of the Oral Rinse product as business and marketing model.

Last year, Xttrium Laboratories added a new dimension to their retail product line by adding a Private Label (store brand) CHG Solution Antiseptic Skin Cleanser -- 4% Chlorhexidine Gluconate Skin Cleanser. In November, a major retail drug chain added the product to their Health & Wellness (First Aid) Department in over 7,000 stores and initial sales have exceeded initial objectives. We are currently expanding this business to other major retail chains and drug wholesalers.


20% SOLUTION

Xttrium Laboratories is the largest supplier of 20% USP Chlorhexidine Gluconate. This aqueous solution is widely utilized across the medical, dental, veterinary, cosmetic and dairy industries in the formulation of a broad variety of products, both as a preservative and as an antibacterial/antiseptic agent.

A surge in interest and technical research for new applications of CHG continues worldwide, and the future promises tremendous expansion of Chlorhexidine Gluconate usage. Xttrium will continue, as we have for many years, to be in the forefront of Chlorhexidine supply and research.

PACKAGING (20% USP CHG )
Container Size Kg of Liquid Lb of Liquid
5 Gallon Pail 20 Kg 44.09 lb
55 Gallon Drum 200 Kg 440.9 lb
250 Gallon Tote 1000.0 Kg 2204.6 lb