United-Guardian, Inc., through its Guardian Laboratories division, manufactures and markets cosmetic ingredients, pharmaceutical products, medical lubricants and sexual wellness ingredients.
In October 2023, the company entered into a distribution agreement with Brenntag Specialties, a global market leader in chemicals and ingredients distribution, for the distribution of the company’s new Natrajel line of sexual wellness ingredients in the United States, Canada, Mexico, Central America and So...
United-Guardian, Inc., through its Guardian Laboratories division, manufactures and markets cosmetic ingredients, pharmaceutical products, medical lubricants and sexual wellness ingredients.
In October 2023, the company entered into a distribution agreement with Brenntag Specialties, a global market leader in chemicals and ingredients distribution, for the distribution of the company’s new Natrajel line of sexual wellness ingredients in the United States, Canada, Mexico, Central America and South America.
The company conducts various research and development activities. The company’s research and development department primarily develops new and unique cosmetic ingredients. The company develops new products using natural and environmentally friendly raw materials, which is a priority to many of its cosmetic customers. The company’s research and development department also modifies, refines, and expands the uses for existing products, with the goal of further developing the markets that its products are used in. All the products that the company markets, except for Renacidin, are produced at its facility in Hauppauge, New York. Renacidin, a urological product, is manufactured for the company by an outside contract manufacturer.
The company uses its product development and formulation expertise to maintain its market position and to propel future growth. The company also focuses on the development of new products that fill unmet market needs and have unique properties.
The company’s products are sold into stable and growing markets, such as personal care, medical devices and pharmaceuticals. The company’s product offerings include cosmetic ingredients, medical lubricants, pharmaceuticals and sexual wellness ingredients.
The company’s product offerings are segregated into the following categories:
Cosmetic Ingredients: Cosmetic ingredients include an extensive line of multifunctional hydrogel formulations designed to offer sensory enhancement, lubrication, texture and moisturization to personal care products.
Medical Lubricants: Medical lubricants include a line of hydrogel formulations designed to offer sensory enhancement and lubrication to medical products.
Pharmaceutical Products: Pharmaceutical products include an FDA approved prescription drug that is used primarily to prevent and to dissolve calcifications in urethral catheters, as well as a chlorine-based topical antimicrobial.
Sexual Wellness Ingredients: Sexual wellness ingredients include a line of hydrogel formulations designed to offer sensory enhancement, lubrication and moisturization to sexual wellness applications.
Business
The company manufactures and markets cosmetic ingredients, pharmaceuticals, medical lubricants and sexual wellness ingredients.
The company also conducts research and development, primarily related to the development of new and unique cosmetic ingredients and medical lubricants. The company focuses on the development of products that fill unmet market needs, has unique properties, and use proprietary technology that it typically protects as trade secrets rather than with patents. Many of the company’s products are marketed through collaborative distribution agreements with larger companies.
The cosmetic ingredients manufactured by the company are marketed to end users through its worldwide network of distributors and are used by many of the major manufacturers of cosmetic products. One of the company’s most important product lines is its Lubrajel line of multifunctional hydrogel formulations, which are designed to provide sensory enhancement, lubrication, hydration, and texture to both personal care and medical products. In the last few years, to meet the growing demand for green and sustainable products, the company focuses on developing and launching new products which only contain ingredients that are considered natural. The company’s Lubrajel products in the new natural line have been certified by the Cosmetic Organic and Natural Standard (COSMOS). This standard is recognized globally by the cosmetic industry. The company ships its cosmetic ingredients to its distributors Ex Works (EXW) from its facility in Hauppauge, New York. Those distributors in turn resell those products to their customers, who are typically the manufacturers and marketers of cosmetic and personal care products.
The ocmpany’s pharmaceutical products are sold primarily to several full-line drug wholesalers which in turn supply those products to pharmacies, physicians, and hospitals.
The company operates in one business segment. The company’s products are separated into four distinct product categories: cosmetic ingredients, pharmaceuticals, medical lubricants and sexual wellness. Each product category is marketed differently. Effective July 1, 2023, the company discontinued its industrial product line of products. Beginning in 2024, the Company added sexual wellness ingredients to its portfolio of product categories.
The company’s cosmetic ingredients are marketed globally by five distributors, of which Ashland Specialty Ingredients (ASI), a business segment of Ashland, Inc., is the largest. ASI manufactures and markets globally an extensive line of personal care and pharmaceutical additives and various other specialty products. The company sells its cosmetic ingredients directly to those distributors, which in turn resell its products to their customers for use in the formulation of one or more of the customers’ personal care and cosmetic products. The company’s non-pharmaceutical medical lubricants are sold directly to marketers of finished medical products or to the contract manufacturers utilized by those marketers. The company markets its pharmaceutical products primarily through its dedicated Renacidin website. The pharmaceutical products are sold to hospitals and pharmacies primarily through full-line drug wholesalers, which purchase its products outright for resale to their customers. The company also sells a small quantity of pharmaceutical products directly to hospitals and pharmacies. The company’s products are sold under trademarks or trade names that it owns, some of which are registered with the United States Patent and Trademark Office, as well as with comparable regulatory agencies in some foreign countries. The company maintains a corporate website at www.u-g.com, and a specific website for Renacidin at www.renacidin.com.
Products
The company operates in one business segment, and its current product lines are separated into four distinct categories:
Cosmetic Ingredients
The cosmetic ingredients the company manufactures are marketed and sold to end users through its worldwide network of distributors. The company’s cosmetic ingredients are sold globally by five distributors, of which Ashland Specialty Ingredients (ASI), a business segment of Ashland, Inc., is the largest. ASI. is the exclusive distributor of its products in the United States, Canada, Asia, South & Central America, Mexico, Europe (all regions other than France, the United Kingdom, Italy & Switzerland), Scandinavia, Africa, Australia, the Middle East and Korea. The company’s other cosmetic ingredient distributors are Azelis UK Ltd in the United Kingdom, Sederma SAS, a subsidiary of Croda International Plc., in France, Safic-Alcan S.p.A. in Italy, and Azelis Cosmetics GmbH in Switzerland. The company is in the process of renegotiating some of its distribution agreements.
The company ships its cosmetic ingredients to its distributors EXW from its facility in Hauppauge, New York. The distributors resell the products to their customers, which are typically major manufacturers and marketers of cosmetic and personal care products. They utilize the company’s products in their finished products.
Since the company’s Lubrajel hydrogels are well-known and established specialties that in the event ASI or any of its other cosmetic product distributors were to cease marketing and selling its products, alternative distribution agreements could be signed with other distributors of cosmetic ingredients in the affected territory or territories.
Products - cosmetic ingredients:
LUBRAJEL is an extensive line of multifunctional hydrogel formulations designed to mainly provide sensory enhancement, lubrication, and texture to personal care products. Some of the Lubrajel products also offer skin moisturization benefits. The Lubrajel products are primarily used in skin care products, such as moisturizers, anti-aging creams, body lotions, face serums, spa products and sunscreens. The Lubrajel products are also used in makeup products, such as primers and foundations. Each Lubrajel product offers unique benefits for the formulation of skin care and color cosmetic products. The basic product line includes Lubrajel CG, Lubrajel DV, Lubrajel IIXD, Lubrajel MS, Lubrajel NP and Lubrajel Oil.
To address customer demand for preservative-free products, the company developed and launched Lubrajel DV PF, Lubrajel IIXD PF, Lubrajel MS PF, Lubrajel Oil PF and Lubrajel PF. To address customer demand for paraben-free products, the company developed and launched Lubrajel DV free, Lubrajel IIXD free, Lubrajel MS free, Lubrajel NP Free and Lubrajel Oil free.
The Lubrajel products in the new natural line have been certified by the Cosmetic Organic and Natural Standard (COSMOS). The new natural line of products includes Lubrajel Natural, Lubrajel Marine, Lubrajel Oil Natural and Lubrajel Terra. All of the natural products are designed using green technology and contain natural raw materials. These products are multifunctional, Roundtable on Sustainable Palm Oil (RSPO) certified, Vegan, biodegradable and COSMOS approved.
In addition to the Lubrajel line of products, the company manufactures the following additional cosmetic ingredients, which accounted for less than 10% of total sales in 2023:
B-122 is a powdered lubricant used in the manufacture of certain cosmetics, such as pressed powders, eyeliners, and rouges, as well as some industrial products.
ORCHID COMPLEX is an oil-based extract of fresh orchids. It is characterized by its excellent lubricity, spreadability, light feel, and emolliency. Because of its alcohol solubility it may also be used in fragrance products, such as perfumes and toiletries. Its emolliency makes it an excellent additive to shampoos, bath products and facial cleansers.
LUBRASIL II SB is a special formulation of Lubrajel in which silicone oil is incorporated into a Lubrajel base using proprietary technology that enables the product to maintain much of the clarity of regular Lubrajel. The product has a silky feel and is water resistant while at the same time providing moisturization. Sales of the company’s cosmetic ingredients represented approximately 38% of its total sales for the years ended December 31, 2023.
Medical Lubricants
The company’s medical lubricants are sold directly to manufacturers and marketers of finished medical products or to the contract manufacturers utilized by those companies. Sales of the company’s medical lubricants are shipped EXW from its facility in Hauppauge, New York.
Products – Medical Lubricants
The company’s medical lubricants are also sold under the Lubrajel brand since they are hydrogel formulations designed to provide sensory enhancement and lubrication to medical products. The Lubrajel medical lubricant products are primarily used in catheters, condoms, personal lubricants and in oral care applications, such as mouthwashes.
The company offers medical lubricant products for catheter lubrication, medical devices, condom lubrication and oral care. In addition, the company develops and sells customized exclusive products for all these applications.
The company’s medical lubricants include Lubrajel MG, Lubrajel MGL, Lubrajel RRCG, Lubrajel RR, Lubrajel RC, Lubrajel RA, Lubrajel Fluid, Lubrajel LC, Lubrajel BA, and Lubrajel FACO.
Lubrajel MG and Lubrajel MGL are the company’s standard medical lubricants and can be applied to catheters, thermometers and other instruments to ensure ease of use and patient comfort. The company’s R-line of products, Lubrajel RRCG, Lubrajel RR, Lubrajel RC and Lubrajel RA can withstand sterilization by gamma radiation, which is one of the methods of terminally sterilizing medical and hospital products. Lubrajel Fluid is designed as an alternative to traditional silicone-based lubricants. The water-based formula offers easy clean up and is non-staining. It is compatible with traditional condom release powders which are used during the manufacture of latex condoms.
Lubrajel LC, Lubrajel BA and Lubrajel FACO are hydrogel formulations developed for use in oral care applications.
Sales of medical lubricants represented approximately 16% of the company’s total sales for the years ended December 31, 2023. There is potential to continue growing the sales of the company’s medical lubricants through new product development, development of new product applications and markets, and geographic expansion.
Pharmaceuticals
The company sells its pharmaceutical products primarily to full-line drug wholesalers, which in turn supply those products to pharmacies, physicians, hospitals, long-term care facilities, the U.S. Department of Veterans Affairs, and other government agencies. The company also sells a small quantity of pharmaceutical products directly to hospitals and pharmacies. The company arranges for, and covers the cost of, shipping its pharmaceutical products, and sales of those products are final when shipped.
Products - Pharmaceuticals
RENACIDIN is a prescription drug approved by the FDA that is used primarily to prevent and to dissolve calcifications in urethral catheters. The company maintains a specific website dedicated to this product at www.renacidin.com.
CLORPACTIN WCS-90 (Clorpactin) is a chlorine-based drug that is marketed as a topical antimicrobial and is also used in urology. It is also a powerful disinfectant, fungicide, and deodorizer.
The company’s pharmaceutical products represented 45% of its total sales for the year ended December 31, 2023. There is potential to grow the sales of the company’s pharmaceutical products through geographic expansion.
Sexual Wellness Ingredients
Sexual wellness ingredients is a line of hydrogel formulations designed to offer sensory enhancement, lubrication, and moisturization to sexual wellness applications.
The new Natrajel line of products comprises Natrajel NT, Natrajel MA, Natrajel ON and Natrajel TE. This line was designed using green technology and contains natural raw materials. All the products are RSPO certified, Vegan, biodegradable and COSMOS approved.
Foreign Sales
For the year ended December 31, 2023, approximately 21% of the company’s sales revenue was from foreign sources, and was derived from sales of its cosmetic ingredients to foreign distributors, which accounted for approximately 7% of sales, for the year ended December 31, 2023, and sales of medical lubricants directly to certain customers in foreign countries, which accounted for approximately 14% of its sales revenue for the year ended December 31, 2023.
Because all shipments to the company’s largest distributor, ASI, are delivered to ASI’s warehouses in the U.S., all sales to ASI are considered domestic sales, even though a significant percentage of ASI’s sales of its products are to customers in foreign countries.
Domestic Sales
For the years ended December 31, 2023, approximately 79% of the company’s sales were from domestic sources, which represents sales within the United States only.
Cosmetic Ingredients
Domestic sales of cosmetic ingredients accounted for approximately 31% of total sales in 2023. Sales to the company’s largest distributor, ASI, accounted for approximately 30% of total sales in 2023.
Pharmaceuticals
The company’s pharmaceutical products are marketed only in the United States and are sold primarily through full-line drug wholesalers. Sales of those products accounted for approximately 45% of sales in 2023.
During 2023, the company participated in various government drug rebate programs related to the sale of Renacidin, its most important pharmaceutical product. These programs include the Veterans Affairs Federal Supply Schedule (FSS), and the Medicare Part D Coverage Gap Discount Program (CGDP). These programs require the company to sell its product at a discounted price, typically given in the form of a rebate.
Medical lubricants
The company sells its medical lubricants directly to end users or to contract manufacturers utilized by the end users. Domestic sales of medical lubricants accounted for approximately 3% of the company’s total sales in both 2023 and 2022. Although all shipments of medical lubricants to the U.S. locations are considered domestic sales, a percentage of those shipments are subsequently shipped by some customers to foreign manufacturing facilities, which then produce finished products that could be marketed globally.
ISO 9001:2015 Certification
On July 23, 2018, the company is certified by DQS Inc. to be in compliance with the latest ISO standard, ISO 9001:2015, indicating that its documented procedures and overall operations had attained the high level of quality needed to comply with this ISO certification level.
Intellectual Property
The company owns the Lubrajel, Renacidin, Clorpactin, Excellence Through Innovation, and Natrajel trademarks.
Customers
The company’s cosmetic ingredients are marketed and sold globally by five distributors. Those distributors, in turn, market and distribute those products to their customers. The company’s pharmaceutical products are sold to, and distributed by, full-line drug wholesalers throughout the United States. The company’s medical products are sold directly by it to the end users of those products or, in some cases, to contract manufacturers used by some of those end users.
Research and Development
The company’s research and development expenses in 2023 were $463,992.
Government Regulation
The company’s operations and many of its products are subject to chemical control laws. These laws include regulation of chemical substances and inventories under and the Registration, Evaluation and Authorization of Chemicals (REACH) regulation in Europe, Right to Know laws under the Global Harmonized System (GHS) for hazard communication, and the regulation of chemicals used in the manufacture of pharmaceuticals and personal care products and contact food under the Food, Drug and Cosmetics Act in the United States. The company is an FDA Drug Establishment registered site.
The company is required to comply with all pertinent current Good Manufacturing Practices of the U.S. Food & Drug Administration (FDA) for medical devices and drugs its products may be subject to. The company’s present and future activities are, and will likely continue to be, subject to varying degrees of additional regulation under the Occupational Safety and Health Act, Environmental Protection Act, import, export and customs regulations, and other present and possible future foreign, federal, state and local regulations.
History
United-Guardian, Inc. was founded in 1942. The company was incorporated in 1987.
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