NEWS LETTER

Hi, how are you?

We are proud to announce that, following its official registration as a U.S. FDA OTC (Over-The-Counter) manufacturer, OTCM successfully held its facility opening ceremony on July 1.

The newly completed OTCM plant was established to meet the rigorous regulatory requirements for exporting OTC cosmetics to the United States. The event was attended by a wide range of guests—including brand clients, raw material and packaging suppliers, and equipment partners—who joined us in celebrating this meaningful milestone.

■ OTC and MoCRA Compliance Demands Pharmaceutical-Level Manufacturing

The U.S. FDA classifies certain functional cosmetics, such as sunscreens, acne treatments, and tooth-whitening products, as OTC drugs. These products must comply with cGMP (Current Good Manufacturing Practices), the same standards applied to pharmaceuticals.

As such, OTC manufacturers must be registered with the FDA, verify product safety, and demonstrate readiness for FDA inspections. These requirements go well beyond those of conventional cosmetics manufacturing.

Furthermore, with the enactment of the Modernization of Cosmetics Regulation Act (MoCRA) in late 2022, even non-OTC cosmetics are now subject to facility registration. For brands aiming to export to the U.S., partnering with a manufacturer capable of meeting GMP-related compliance and inspection readiness is more essential than ever.

■ OTCM’s Design Philosophy: Advanced Systems Built for Compliance

To directly address these evolving regulations, OTCM was designed with a fully enclosed automated production system and a digitally integrated quality management platform. These systems—presented during the ceremony—ensure the facility maintains FDA-level cGMP conditions at all times and is fully prepared for unscheduled inspections.

■ Global Demand Secured Prior to Completion

Even before its official launch, OTCM had secured production orders from global clients and has now commenced full-scale commercial manufacturing.

During the opening ceremony, appreciation plaques and symbolic “keys of good fortune” were presented to our valued customers. Production is now actively underway for brands including Globe in a Bottle (U.S.), Allion (Singapore), and partners from Türkiye and Russia.

■ Beyond Production: A Total Platform for Regulatory Success

OTCM offers more than just OEM/ODM services. We provide a comprehensive partnership platform, including FDA registration support, formulation development, safety documentation, and regulatory strategy.

As a full-cycle solution provider, OTCM is committed to helping both domestic and international brands successfully enter the U.S. market by supporting every step—from product planning to pre-launch.

We will continue to strengthen our capabilities as a trusted, compliance-driven manufacturing platform for global export success.

For inquiries, please contact us using the information below.

Duhyun Kim / Sales Director

E-mail: dhkim@otcmfg.com 

Sincerely,
The OTCM Team