2020 KUKJEON - Companybrief - EN - Ver2022.09.22

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COMPANY HEAD

03 INTRODUCTION 10
GMP
CONTENT QUARTE
R
ADVANCE
15 PRODUCTION S D 22
FACILITIES MATERIA
L
for electronics
industry
WE ARE
AURORE LIFE SCIENCES

The fastest growing pure-play


API maker with a focus on
delivering the highest quality
APIs backed by robust R&D.

VISION / VALUE
04 OVERVIEW
05
LOCATION
06
HISTORY
07 BUSINESS AREA
08 TURNOVER
VISION / VALUE

To attain leadership position in the generic API arena by focusing on Innovation,


Quality & Cost Optimization.

QUALITY COST-OPTIMIZATION INNOVATION


Capitalize on group’s R&D Use R&D Strength to improve cost and Build and retain strong IP for
capabilities to churn out technological efficiencies of the the developed products and
robust APIs with competitive existing products make effective foray into high
positioning and global play value markets
OVERVIEW

ESTABLISHED : 2017
CEO : MR. RAJENDER RAO JUVVADI

EMPLOYEE : 1500

Corporate Office ALS Site APL Site R&D Center


Hitec City, Hyderabad, Jeedimetla, Hyderabad, Kazipally, Hyderabad, Shapur, Hyderabad,
Telangana. Telangana. Telangana. Telangana.
HISTORY

2017 - 2019 – 2021 2021 - Current


2019
• Established R&D • Fastest to launch Favipiravir • Kazipally facility with
• Acquired Kopalle and only firm to provide 386 KL made fully
pharmaceuticals to get intermediate to innovator. operational.
a head start. • Commencement of phase-1 • EDQM Approval for
• Acquisition of Mylan site at Kazipally. APL site.
( Viatris ) API facility. • Construction of phase-2 • WHO Geneva
• Construction of Kazipally site, 200KL. approval.
Greenfield site ( phase • One of the first companies
1 ) 180 KL to develop Molnupiravir.
BUSINESS
AREA

Importing & Registration API


Exporting with MFDS production
APIs

Quality Importing Research & License


& Development IN &
analysis Exporting for
OUT
innovative
service Electronics new product
materials
semiconductors,
displays, rechargeable
batteries and cosmetics
material
KUKJEON
PHARMACEUTICAL
ENRICHING LIVES
AND SHARING
HOPE WITH THE
WORLD

HEAD
QUARTE
R

ORGANIZATION 11
COMPETITIVENESS 12
REGISTRATIONS
13 GLOBAL NETWORK
14
KUKJEON
ORGAN
PHARMACEUTI
CAL
1
1
IZATIO
N
HEAD
OFFICE

Busines
Bio & Pharma Sales
s
Strategy
Div Div.
Div.

Over API RA Biz Sale


s AT Account Finance HR
seas Planning Development Tea
Sales Purchasi Tea S Team Team Team
Team Team m m
ng Team Quality
Pharmaceutical Strategic
Bio Research Management Planning
Institute Team ( QC / QA ) Team
AURORE LIFE SCIENCES
Regulatory Strength

VALACYCLOVIR ANHYDROUS
CEP APPROVED

Satisfy customer
needs
500+
250+ global network andLicense & DMF
partners
KUKJEON
REGISTRATIONS
PHARMACEUTICAL 13

Number of APIs
registration to MFDS
by Kukjeon
(Import License &
KDMF)
Year 1972 - 2012 2013 - 2016 2017 - CURRENT TOTAL
GMP 275 36 9 320
517
K-DMF 49 68 80 197
KUKJEON
GLOBAL
PHARMACEUTICAL 14

NETWORK
Global Partners
Kukjeon's main business is distribution of imported APIs in the domestic
market and to achieve success in the finished product business of our
customers.
KUKJEON
PHARMACEUTICAL
ENRICHING LIVES
AND SHARING
HOPE WITH THE
WORLD

GMP
PRODUCTIO
N FACILITIES

MISSION 16
ORGANIZATION 17
INTRODUCTION
18 HIGH LEVEL OF QUALITY MANAGEMENT
20 API LIST
21
KUKJEON
MISSIO
PHARMACEUTICAL 16

KUKJEON PHARMACEUTICAL Co., LTD manufacturing


facilities
operate following stringent compliance with regulations.

1 2 3
QUALITY CUSTOMER SAFETY
Accommodation with Strict observance of More intensive
systematic facility customer requirements and accommodation of safety
management for the supply regulatory authority’s regulations in order to
of highest quality product. regulation. establish safe business.
KUKJEON
ORGAN
PHARMACEUTI
CAL
1
7
IZATIO
N FACTORY

Hyangnam Site

Production Synthesis Operatio


& n
Quality Support

Synthesis Synthesis Storage


Purchasin Productio
Contro
g n l
QC Operation Environmen
Developmen t Safety
t
Synthesi
QA
s
Analysi
s
KUKJEON
INTRODUCTIO
PHARMACEUTICAL 18

N
We Operate 40 + Kinds of physical
& Chemical and microbiological analysis
equipment.
Multiple sizes Pilot
Reaction Utility
production &kilo
Facilities lab

· STS reactors: 5m3, 3m3, 1m3, 0.5m3 · Common Organic Synthetic Reactions · G/L: 0.1m3 x 2ea · HVAC System
· G/L reactors: 5m3, 2m3 (Oxidation, Reduction (ambient and (Buchi · Purified
· Pulverizer: Air jet mill, pin mill medium pressures), Esterification, Chemreactor Water
· Nutsche Filter: 0.6m , 0.2m
3 3
Sulfonation, Amination, Acylation, system) System
· Tray Vacuum Dryer: 5m3, 3m3, 2m3, Thiolation etc.) · Nutsche Filter: · Air
0.2m3 · Representative technology of synthetic 0.1m3 Compressor
· Disk Filter Housing · Pilot independent
organic reaction (Friedel-Crafts System
· STS Feeding Tank: 0.2m3 operation · liquid
reaction, Diels-Alder Reaction, Wittig
· Clean Booth System
reaction etc.) nitrogen(N2)
· Hot Water system · Chiral synthesis and resolution System
· Explosion-proof electrical equipment · Other manufacturing technology (Low-
temp. reaction -20℃,
Drying/Grinding etc.)
· Reductive amination
KUKJEON
INTRODUCTIO
PHARMACEUTICAL 19

Trust one who has proved it !


Trust an expert
!
KUKJEON
HIGH LEVEL OF QUALITY
PHARMACEUTICAL 20

MANAGEMENT

Skilled and Complying with the Extensive Prompt and


experienced ICH guideline and experience of cooperative
RA experts high level GMP regulatory technical service
standards to customers
inspections

Approval of Genotoxicity NDMA / NDEA / NMBA


GMP by /
Impurity DIPNA / EIPNA
MFDS study (Derek &
and Sarah) study
PMDA
KUKJEON
ACTIVE PHARMACEUTICAL INGREDIENTS
PHARMACEUTICAL 21

(API)
Product name Indication Specification

Benfotiamine Vitamine B1 KP

Choline Alfoscerate Nootropics & Neurotonics KP/In house


Cinacalcet HCl Thyroid & related drugs In house
Dibucaine HCl Local anesthetics USP
Doxycycline monohydrate Tetracycline antibiotics In house
Enoxolone Anti-inflammatory agents EP
Epinastine HCl Antihistamines & antiallergics EP
Escitalopram Oxalate SSRIs: Selective serotonin reuptake inhibitors USP
Hinokitiol Antibacterial agents In house
Ibuprofen Arginine NSAIDs In house
Itopride HCl GI tract regulators & antispasmodics In house
Loxoprofen Sodium NSAIDs JP
Nafamostat Mesilate Anticoagulants JP
Solifenacin succinate Genitourinary smooth muscle relaxants In house
Spherical Carbonaceouse Adsorbent Antidotes In house
KUKJEON
PHARMACEUTICAL
ENRICHING LIVES
AND SHARING
HOPE WITH THE
WORLD

ADVANCE
D
MATERIAL
for
electronics
industry

INTRODUCTION
23 BUSINESS AREA
24 HOW WE WORK
25
KUKJEON
INTRODUCTIO
PHARMACEUTICAL 23

OUR CORE ACTIVITY OUR R&D INSTITUTE THE


is to develop new materials is composed of skilled R&D DIFFERENTIATED
that are distinguished and personnel in organic synthesis with
improved global supply / manufacturer
advanced expertise and experience.
especially in functions and network unique to KUKJEON
In joint research with customers,
properties, through the Pharmaceutical is an accumulated
we provide molecular design and
collaboration with the companies core competency that no one can
related technical support and
locally and globally leading in easily copy, built on decades of
produce new target materials.
Semiconductor, Display, and experience in import, distribution, and
Secondary battery industry. production of drug substances, so
that we can demonstrate various
coping abilities and cost-effective
access to research processes and
commercial production.
KUKJEON
BUSINESS
PHARMACEUTICAL 24

AREA

Display Semiconductor
Materials Materials
· Antistatic agents · Spin-on Hardmasks
· Low-k dielectric (monomer & polymer
monomer & )
polymer
· UV hardening
agents Business
Area
Secondar
y Battery OLED
· Low resistance
Intermediates
Electrolyte · Carbazole intermediates
· Phosphine compound · Boric acid intermediates
· Silane compound · Fluorene intermediates
· Boron compound
KUKJEON
HOW WE
PHARMACEUTICAL 25

WORK

Strategic
collaboration Competitive
with overseas
partners commercial
production
Lab sample,
Pilot sample Spec,
Test Method Set-
up
Process
Development
&
Optimization
HOW Project creation
WE through customer needs
WORK
THANK
YOU

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