Paving Way for Expansion in Overseas Markets
K.S.PEARL, a cosmetic ingredient specialist company established in 1986, has been supplying innovative and safe cosmetic ingredients and stands shoulder to shoulder with global material companies. Recently, K.S.PEARL has attracted the attention of the industry.
This attention comes as K.S.PEARL successfully passed the U.S. Food and Drug Administration (FDA) inspection for its Over The Counter (OTC) sunscreen product ingredients. In July, the FDA visited K.S.PEARL’s Incheon plant to inspect the manufacturing facilities for the Active Pharmaceutical Ingredients (API) of sunscreen products. In early October, K.S.PEARL received an Establishment Inspection Report (EIR) stating that their facilities comply with the Good Manufacturing Practice (GMP) standards.
In South Korea, sunscreen products are classified as functional cosmetics. They can be produced without any issues once they pass an assessment for quality, safety, and efficacy by the Ministry of Food and Drug Safety. However, in the U.S., sunscreens are classified as OTC drugs. Therefore, facilities and products must be registered with the FDA and undergo regular inspections. Meeting the strict and demanding standards for APIs, rather than cosmetic ingredients, makes passing these inspections challenging.
As the global cosmetics market becomes more international, passing FDA inspections is becoming a mandatory condition not only in the U.S. but also in Europe and Asia. Global cosmetics companies consider U.S. market compliance from the product development stage, as it’s the largest market. Also, passing FDA inspection is proof of a company’s strict production and quality control. Despite its importance, even leading global material companies sometimes fail or give up on passing FDA inspections, which is changing the dynamics of leadership in the global market.
In this context, K.S.PEARL’s successful FDA inspection for its sunscreen products is clearly a significant opportunity to strengthen its leadership in not just the North American but also the global market. Since completing FDA facility registration in 2016 and preparing for the export of pharmaceutical ingredients to the U.S., K.S.PEARL started exporting sunscreen pharmaceutical ingredients to the North American market in 2019. This passing FDA inspectionsval is the meaningful outcome of a decade-long investment in predicting global trends and a milestone in expanding into overseas markets.
Regarding this achievement, K.S.PEARL’s CEO, Kim Moon-ki, said, “The sunscreen market is now focusing on inorganic sunscreens like TiO2 and ZnO, which are recognized as safe and effective by the U.S. FDA. With the recent FDA inspection approval, these products manufactured at our Incheon plant will become key products in our global export strategy.”
K.S.PEARL has been leading the trend in cosmetic ingredient production and sales by listening to customer needs and continually developing innovative products. With the successful FDA inspection of its sunscreen products, the company plans to further enhance its reputation as a specialist in cosmetic ingredients, a legacy built over more than 30 years. K.S.PEARL, having secured additional factory land in the Namdong Industrial Complex in Incheon this past September and expanding its production lines, is expected to strengthen its position both domestically and internationally.
