[Edaily Reporter Shin Min-jun] #RPBio, a contract development and manufacturing organization (CDMO) specializing in health functional foods and pharmaceuticals, has successfully passed an on-site inspection by the U.S. Food and Drug Administration (FDA) at its Mado health functional food plant.

RP Bio announced on the 11th that its Mado health functional food plant has officially passed the FDA’s on-site inspection, receiving a “Voluntary Action Indicated” (VAI) determination.

The inspection was conducted over five days, from January 5 to 9, at the Mado health functional food plant located in Hwaseong, Gyeonggi Province. The final results of the FDA inspection have now been officially recorded on the FDA’s official data dashboard.

The FDA’s VAI designation is a passing grade indicating that the manufacturing facility’s overall quality management system (cGMP) complies with global standards and that there are no legal or regulatory issues regarding full-scale operation and export.

Park Jin-hyung, Head of Sales at RP Bio, stated, “By successfully passing the on-site inspection by the U.S. FDA, which is known to have the highest entry barriers in the dietary supplement market, we have completely resolved global regulatory risks.”

Building on this achievement, RP Bio will accelerate its business-to-business (B2B) sales efforts targeting major domestic and international pharmaceutical companies and global brands. In particular, RP Bio is now able to provide a solid guarantee of quality as an export-ready manufacturing partner for clients preparing to enter global markets, including the U.S.

AlpBio possesses advanced manufacturing processes and differentiated formulation technology at its Mado plant. The company is expanding its new order contracts by leveraging its unique lineup of optimized formulations—including soft capsules, functional jellies, and chewables—targeted at “Slow Aging” (a philosophy of managing the aging process), which has recently established itself as a major trend in the health supplement market.

AlpBio has maintained the top market share position in the domestic soft capsule manufacturing market for over 40 years, since the 1980s. As a specialized soft capsule manufacturer, AlpBio is known to have originated from Korea AlpScherer, which was established in 1983 as a joint venture between Daewoong Pharmaceutical and Catalent (formerly AlpScherer), a U.S.-based soft capsule company. Korea RPI Scherer changed its name to RPI Co. following a merger with Daewoong Trading in 2012. AlpiBio was established in 2016 through a spin-off from RPI Co.

Noh Mi-seon, Head of Marketing at AlpBio, stated, “Passing this FDA inspection is the result of combining our strict quality control capabilities, accumulated over a long period, with production infrastructure that meets global standards.” She added, “Based on our established quality reliability, AlpBio will actively support our clients’ expansion into overseas markets while achieving substantial revenue growth through aggressive expansion of global CDMO orders.”