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API

API distribution: 248 DMF registrations and exclusive supply from 14 manufacturers in 7 countries

Your Trusted Partner for
Pharmaceutical & Biotech Raw Materials

Since 2004, we have supplied active pharmaceutical ingredients (APIs), excipients, and raw materials for the cosmetic and food industries across Korea.
From sourcing and supply agreements to regulatory registration, warehousing, and delivery, we manage the entire process in-house.

Raw Material Supply Business

  • 248 DMF registrations · 51 pharmaceutical product approvals/registrations (cumulative as of August 2026)
  • Exclusive supply agreements with 14 manufacturers across 7 countries
  • Over 220 products across four key sectors: APIs, excipients, cosmetics, and food ingredients
  • Authorized domestic supplier of excipients from Evonik (Germany) and SEPPIC (France)
  • In-house warehousing, QC, and distribution through our Hwaseong Logistics Center, operated in compliance with KGSP and KGIP standards
Explore Products
Dispensing an active pharmaceutical ingredient into smaller containers

Fields We Handle

Our Hwaseong Logistics Center features a
dedicated API storage zone alongside
advanced on-site quality control (QC) operations.

Racking in the API storage area of the Hwaseong logistics center

Hwaseong Logistics Center

The Hwaseong Logistics Center operates dedicated storage areas for active pharmaceutical ingredients (APIs).
In 2017, a new logistics warehouse was constructed to expand storage capacity. The facility manages temperature and humidity by designated storage area and also maintains on-site Quality Control (QC) capabilities.

Quality First

Proper storage conditions are essential to maintaining API quality.
Ace Biopharm maintains product quality from receipt through shipment using dedicated storage areas and controlled temperature and humidity. We operate GMP-aligned quality procedures to meet customer requirements and respond to evolving domestic and international regulations.

A researcher checking a sample under a microscope in a cleanroom

Quality Operating System

  1. 01Change Control

    Changes to processes and specifications are documented and subject to an approval process.
    All changes are traceable through documented records maintained before and after implementation.

  2. 02Deviation Management

    Deviations from established standards are documented and investigated to identify their causes.
    The results of the investigation and subsequent actions are documented and maintained.

  3. 03Corrective and Preventive Action (CAPA)

    Corrective and preventive actions are established to prevent recurrence.
    The effectiveness of the implemented actions is also evaluated.

  4. 04Risk Management

    The potential impact of changes and deviations on product quality is assessed in advance, and priorities are established accordingly.
    Risk levels are reassessed after the implementation of appropriate actions.

Quality Control Process

  1. Incoming Inspection

    Specification · condition check

  2. Quality Control

    1. Awaiting testing
    2. Analysis
    3. Approved

  3. Storage

    Temperature · humidity
    controlled zone

  4. Shipment

    Final Release Check

Change control · deviation management · CAPA · risk management: every step is managed on record

DMF Registration Status

A Drug Master File (DMF) contains information on the manufacturing process, quality, and stability of an API and is submitted to the Ministry of Food and Drug Safety (MFDS).
As of August 2026, Ace Biopharm has 248 cumulative DMF registrations and 51 pharmaceutical product registrations.
DMF registrations have increased 2.6-fold, from 91 in 2020 to 248 as of August 2026. In 2025 alone, 61 new DMF registrations were completed, the highest annual number to date.

New DMF registrations and cumulative total by year
YearNumber of RegistrationTotal Number of Registration (Cumulative count)
2011 ~ 20163030
2017838
20181654
20192680
20201191
202136127
202220147
202312159
202418177
202561232
2026 (as of August)16248