HUMEDIX

Company Profile

By Global business dept.

 Table of Contents

01 Company Introduction 02 Business

I. Company Profile I. Business Overview
II. Company History & Achievement II. Core Ability & Key Values
III. Vision & Philosophy II. Details-Product Portfolio

03 Research & Patent 04 Facility 05 Pathways to the future

I. Project & Study I. Specification I. Mission & Goals
II. Patent II. Equipments & System
Company Introduction
I. Company Profile

HUMEDIX is a research-focused company for total health care

Business : Medical Device, Medicine, Raw materials, Cosmeceuticals

Capital : USD 4.3 million, 2015

Man power : 98 (23 in R&D)

Manufacturing Facility : GMP, KGMP, BGMP approved grade

 Company Introduction
II. Company History & Achievement

Pharmaceutical
manufacturing License
(KFDA)
KGMP Approved CE Approved
BGMP Approved DMF Approved (SGS/ ISO9001& ISO13485)
HERB VALLY Plant Built Changed company Launched Launched
founded in Jae Cheon nameHVLS High Hyal Plus High Hyal Injection

2003 2006 2007 2008 2009

2010 2012 2013 2014 2015

Changed company FDA Approved Awarded Chang Young Listed on KOSDAQ CFDA Approved
nameHUMEDIX (ELAVIE/Dermal Filler) Sil Prize(KOITA)* (ELAVIE/Dermal Filler)
Government PJT:
Anti-body
Launched HA dermal
Filler

Chang Young Sil Prize(KOITA)* : An industrial award given by the Korea Industrial Technology Association(KOITA).
The award is given to the company of the most contribution to the advancement on the industrial technology .
Company Introduction
III. Vision & Philosophy

Faithful management

Trustworthy company between employees

Enrich
Management of quality
human lives

Assuring quality

Touching management

Move customers heart

Business
I. Business Overview

Filler Medical Cosmeceutical

Cosmetics
Product

BIO
Technology
Raw
Research
Project
R&D
` Materials HA Specialty
Active Ingredients
Study PEGylation
CMO

Medical Devices
Cosmetics
Business
II. Core Ability & Key Values

R&D Commercialization Facility

Injection
Specialized in BT & BIO BGMP/KGMP graded system
Medical Device
Innovative technology Mass-Capable
Cosmetic
Strong RTB data High qualified
New bio materials
CMO/OEM

R&D based Bio Technology implements as Advanced products

in Qualified & mass-capable Manufacturing system
 Business
III. Business Status

Sales Growth Ratio by Business

41
(Unit/Currency : Million/USD)
Pharmaceutical
29.2
60%

23.6 Medical Device

32%
12.7
12.1 Raw Material
3%

Cosmetics
2%
2011 2012 2013 2014 2015
 Business
IV. Details-Product Portfolio : Medical Product
High HA content
ELAVIE High Cross-linkage rate
* LC contains 0.3% of Lidocaine Light Plus/LC High Molecule&purity of HA
* Plus has CE approval ELAVIE

Deep Line Plus/LC
Dermal Filler Excellent in :
ELAVIE ELAVIE Safety
Ultra Volume Plus/LC Lifting
Volumizing
ELAVIE
Duration (Cohesiveness/Persistency)
Derma Shine
Non-Cross Linked
0.3% Lidocaine included
High Hyal
Medical Product HA Medicine (Osteoarthritis) High Molecule&purity of HA
CE Approval High Hyal Plus Identical human fluid
(Osteoarthritis) Easy to Handle
High Eye
(Ophthalmic)
Dexamethasone inj.
Tramadol inj.
Linkomycin inj.
Medicine Ascorbic acid inj.
Ambroxol hydrochloride inj.
Cefaclor capsule
Finasteride
Facility
I. Specification

Operate auto filling machines appropriate to production of

viscous material

Total plottage :3,696.10 Venture manufacturer registered for health supplement

Superior quality management system
Total Building area :2,306.8
- Medical device, Drugs(cGMP)
Processing :API/Prefill - Pharmaceutical raw materials (BGMP)
Capacity : - ISO-13485 (SGS)
In-house standard and management with International
Syringe : 2,500-3,500ea/hr
standard (EP,KP,USP)
API : 1,800-2,000g/batch
Optimal Process Validation
Accurate analysis of quality with state-of-the-art

* Production line set up with FDA regulation : BGMP/KGMP

* Laboratory/QC/Office also located
Facility
II. Equipments & System
SOP-M Materials System

SOP-P Production System

QUALITY SYSTEM SOP-E Facilities & Equipment System

SOP-Q

SOP-L Laboratory Control System

SOP-K Packaging & Labeling System

 Pathways to the future
I. Mission & Goals

New healthcare business New Bio Material

Fundamental Technology Technical Cooperation

development Healthy Life business

Facility Augmentation Enlarge Global business

Thank you
for your attention