Valensa International’s USPlus® Saw Palmetto First of Its Kind to Achieve USP Verified Status

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Valensa International’s USPlus® Saw Palmetto First of Its Kind to Achieve USP Verified Status

USPlus® Saw Palmetto successfully completes USP’s rigorous Dietary Ingredient Verification Program, which evaluates adherence to Good Manufacturing Practices (GMP) and officially recognized quality standards

ORLANDO, Fla. (July 17, 2019) — Valensa International, a prominent nutraceutical company based near Orlando, Florida announced today it successfully passed the United States Pharmacopeia’s (USP) voluntary and rigorous Dietary Ingredient Verification Program (DIVP), demonstrating it meets quality standards for its USPlus® ultra-high pressure, supercritical carbon dioxide extract of saw palmetto.

 

“USP is pleased to recognize Valensa International as the first company to have a saw palmetto extract successfully complete the Dietary Ingredient Verification Program,” said John Atwater, Senior Director of USP Verification Services. “Qualifying for this verification program is an accomplishment that demonstrates Valensa International’s commitment to quality and operating GMP quality systems for the manufacture of dietary ingredients in compliance with officially recognized requirements. It also provides manufacturers of finished products with the ability to easily identify and qualify Valensa International’s supercritical carbon dioxide extract of saw palmetto, known to much of the industry as USPlus®, as a supplier of a quality dietary ingredient they can trust.”

“We’re thrilled to be the first saw palmetto extract in the United States to reach this level, which is critical to our customers who count on delivering quality to the market. This third-party assurance is a key recognition that our USPlus® and supercritical carbon dioxide extraction process meet rigorous, scientifically validated standards,” said Uma Sudhan C.P., CEO of Valensa International. “It is important to us to provide the highest quality products to the market, and by participating in the USP Dietary Ingredient Verification Program we have gone a long way to show we are committed to helping our partners achieve standards that consumers rely on.”

USP DIVP helps ingredient manufacturers ensure compliance with GMP requirements and reduce risk while also providing them with a way to differentiate their dietary ingredients in an increasingly competitive global market. USP’s DIVP tests dietary ingredients, audits manufacturing practices and reviews documentation before the manufacturer earns the use of the USP Verified Mark. Having received recognition from USP, Valensa International was also added to USP’s website, a resource for finished product manufacturers to identify ingredient manufacturers who have earned the right to use the USP mark.

Click here for more information about USP’s Dietary Ingredient Verification Program and the process by which Valensa International was awarded this certification.

About Valensa International / USPlus® Saw Palmetto

Headquartered near Orlando, Florida, Valensa International is a leading nutraceutical provider of science-based, intellectual property-protected ingredients proven to benefit human health and wellness. With more than 60 U.S. and International Patents for Formulations and Manufacturing, Valensa continues to innovate in the following four areas; men’s prostate health, joint health, immunity and healthy aging. Founded in 1999, Valensa International is a wholly-owned subsidiary of EID Parry, and produces the following flagship products, marketed under the brands: Parry Organic Spirulina, Organic USPlus® Saw Palmetto Extract, Zanthin® Natural Astaxanthin and FlexPro MD® Joint Health Formulation. Learn more at valensa.com.  USPlus® is a registered trademark of U.S. Nutraceuticals, Inc.

Hailed as a “Florida Treasure,” Saw Palmetto (Serenoa repens) palms are native to Florida and produce berries, from which oil can be extracted when the berries ripen. In the right dosage of 320 mg, a standardized Saw Palmetto extract supports prostate health and can play a role in men with lower urinary tract symptoms, including optimal urinary flow and control.

USPlus® Saw Palmetto lipid extract also has been tested for inhibition on 5?-reductase, the enzyme which catalyzes conversion of testosterone into dihydrotestosterone (DHT), a hormone that plays a key role in prostate growth. The power of Saw Palmetto lies in the oil extracted from ripened berries, which provide a specific ratio of fatty acids that cannot be imitated. Twenty-seven studies, including 15 randomized controlled trials and 12 observational studies, have successfully demonstrated that a high-quality Saw Palmetto extract, standardized to contain between 70-90% fatty acids, supports men’s urinary health with a low risk of side effects and no observed effect on Prostate-Specific Antigen (PSA).

Valensa, who pioneered the commercialization of standardized Saw Palmetto Extract in the US market back in 2001, begins with a sustainable, wildcraft harvest of ripened berries. After drying, the berries go through a patented, environmentally friendly, ultrahigh-pressure supercritical CO2 extraction process to produce a pure, solvent-free oil.

Learn more at Valensa.com.

About USP’s Ingredient Verification Programs

USP’s Dietary Ingredient Verification Programs offer rigorous third-party verification services to help manufacturers achieve quality management for dietary ingredients used in the manufacture of finished drug products and dietary supplements. Companies whose ingredients meet USP’s comprehensive and stringent verification requirements, are awarded a USP Verified Dietary Ingredient Certificate and use of the appropriate USP Verified Mark. The Mark can be used on the bulk label of each container of USP-verified ingredients, on the certificate of analysis, and on marketing collateral. USP is an authoritative source for quality verification services, because the United States Pharmacopeia-National Formulary (USP-NF) is an official compendium of scientific quality standards for drugs, dietary supplements and their ingredients.

About USP

United States Pharmacopeia is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. USP Dietary Ingredient Verification Services include GMP facility auditing, ingredient quality control, manufacturing documentation review, and ingredient testing. For more information about USP, visit www.usp.org.

For more information about Valensa’s USPlus® Saw Palmetto, please contact Sendhil Pani at s.pani@valensa.com or by calling +1 (352)357-2004

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Note: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Media Contact: David Jahr, (949) 874-2667, davidjahr@mac.com

Valensa International, Media Relations