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Pharmadax Inc - Company Presentation 1
PHARMADAXIMPROVING QUALITY OF LIFE
Pharmadax Inc - Company Presentation 2
Professionalism Honesty Decisiveness
Mission and Vison
Infrastructure
Management Team
Journey so far….
Technology Platforms
Products and Services
Pharmadax Advantage
Content Overview
Professionalism Honesty Decisiveness
Mission and Vision
Pharmadax Inc - Company Presentation 3
Our Mission is to improve quality of
life of all our stakeholders,
Of our Patients; by supplying highquality & cost effective generics
Of our Employees, by offering safe andhealthy work environment
Of our Investors, by conducting businessethically and creating sustainablebusiness value
Our Vision is to build a leading generic
specialty pharmaceutical company withenhanced focus on specialty modifiedrelease and become preferreddevelopment partner for globalorganization.
PHARMADAXIMPROVING QUALITY OF LIFE
Professionalism Honesty Decisiveness
Headquarter and R&D Facility
5F-1, No. 236, Liancheng Rd.,Zhonghe District, New Taipei City23553, Taiwan( R.O.C. )
Total Headcount at HQ: 70 (28 in RnD)Total Area: 1,600 square meters
PHARMADAX focuses on developing and
manufacturing specialty generic drugs and newdrugs. PharmaDax commenced the business in2008 and headquartered in Taipei, Taiwan.
Organization and Functions at headquarter:
Research & DevelopmentGMP ManagementGMP Quality CenterPK ,BiostatisticsClinical ManagementQuality AssuranceAnalytical & Validation ServicesRegulatory complianceAdministration ManagementFinance& AccountingIT
Pharmadax Inc - Company Presentation
PHARMADAX has its manufacturing facilities
located in Guangdong province, China, withcombined capacity of 600 Mn tablets/year withexpansion possibilities for other dosage forms.
Plant A: Capacity of manufacturing 500 Mtablets per year. It is inspected by FDA Twicein 2013 (No 483) and 2016 (One 483), whichexhibits our commitment to compliance andquality
Land Scale: 6,666 square meters.
Plant B: Construction completed in 2014with potential manufacturing capacity of100 M tablets per year, with large expansioncapabilities for other dosage forms
Land Scale: 42,000 square meters.
Professionalism Honesty Decisiveness
Manufacturing Facilities
Total Area: 48,666 square meters
Pharmadax Inc - Company Presentation5
Professionalism Honesty Decisiveness
Our Leaders
Yipin HuangChairman
Huiju ChanPresident
St. John’s University MSc in Industrial PharmacyAnchen Inc.(US)-Director of the Board & Senior VPAnchen Inc. Taiwan Branch-Director of the Board & PresidentEmpax Pharma Inc.-Founder& Director of the Board& President25+ years of experience in pharmaceutical industry
Soochow University EMBA management Anchen Inc. Taiwan Branch-Director of the Board& Vice PresidentEmpax Pharma Inc-Founder& Director of the Board& Vice President 28+ years of experience in pharmaceutical industry
Pharmadax Inc - Company Presentation 6
Professionalism Honesty Decisiveness
Executive Team
Margaret ChoyEVP
University of Southern California MSc in RegulatoryPar Pharmaceuticals - Senior VP, Regulatory Affairs.Anchen Pharmaceuticals Inc. - Senior VP, Regulatory Affairs.Watson Pharmaceuticals – Director, Regulatory Affairs.Filed over 25 US “First to File” ANDA.28+ years of experience in pharmaceutical industry
Pharmadax Inc - Company Presentation 7
Professionalism Honesty Decisiveness
Our journey so far…
Pharmadax Inc - Company Presentation8
2014
2013
2012
2010
2009
2008
ANDA Submission: Quetiapine Fumarate ER Tab (Para IV)
Plant A passed USFDA inspection, Zero 483s, Listing on Taiwan Stock Exchange
FDA approved Levetiracetam ER TabletThe 2nd GMP plant (Plant B) was established in ChinaGMP QC Lab was set up in Taipei, Taiwan
ANDA Submission : Glyburide Tab & Metoprolol Succinate ER Tab
First ANDA Submission : Levetiracetam 750, 500mg ER Tablet ( Keppra® XR )
R&D center was set up in Taipei and ChinaPlant A got FDA production approval in China
The GMP plant was set up in China (Plant A)The headquarter of PharmaDax was established in Taipei
2015
2016
Won the 12th annual Golden Torch Awards of Enterprise Excellence of R.O.C.
Plant A – USFDA GMP Renewal, One 483, EIR received Dec ’16FDA approval and launch of Glyburide Tablets in US
FDA Submission: 3 approved, 2 under review and 7 in pipeline
2011
Quetiapine XR ANDA Approval and Launch in May ‘20172017
Professionalism Honesty Decisiveness
Business Reach
Pharmadax Inc - Company Presentation 9
USA: Focused Market USA being the largest generic market and having management experience in the region, it was the first choice. Current pipeline is focused on blockbuster opportunities, riding the 2nd wave.
China: Next FrontierGenerics had shown exponential growth and Pharmadax will leverage its manufacturing location and have initiated filings in the country, take for collaborative approach to push
Pharmadax Group operates in the
following geographies :
Taiwan USA China Pharmerging
Headquarter: New Taipei City, Taiwan Manufacturing plant: Guangdong Province, China
US office: California, USA European office: Slovenia, EUIndia Office: Mumbai, India
Number of Total Employees : 210
Professionalism Honesty Decisiveness
Dosage Form Development
Pharmadax Inc - Company Presentation 10
Pharmadax is committed to develop
modified release generics in varioustherapeutic segments. The team brings agood mix of innovation and timely executionto ensure efficient dossier filing
We have a patented technology platformof high precision modified release, whichcan be used on large gamut molecules.
Our scientists ensure that this cuttingedge technology continues to be flexibleto bring more bioequivalent products tomarket.
Formulation Development
Manufacturing Process
Number of employees of R&D in TW and CN: 35
Professionalism Honesty Decisiveness
Core Technology
Pharmadax Inc - Company Presentation 11
Pharmadax uses Non- Erosive Adjustable Drug Delivery System “NEADDS” technology
to develop our products with better cost efficiency and enhance process stability.
US Patent : 62/066,917 Oral Controlled Release Matrix Tablet (NEADDS)Product Submitted to FDA Quetiapine Fumarate ER Tablets
Active Pharmaceutical Ingredient
Water Soluble Excipient
Hydrophobic polymer and water insoluble excipient
Pharmadax Inc - Company Presentation 12
MR- ODT:
Modified- Release Orally Disintegrating Tablet
Ttransdermal patches:
Retention in stomach and sustained release
Sustained release gastroretentive dosage form
Professionalism Honesty Decisiveness
Core Technology
Pharmadax Inc - Company Presentation 13
1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H
1.Schizophrenia
(Quetiapine Fumarate ER Tab) P
IV
2.Hypertension (Metoprolol
Succinate ER Tab)
3.Diabetes (Glyburide Tab)
4.Muscle Relaxant P IV
5.ADHD P IV
6.Overactive Bladder P IV
7.Common Cold PIV
8.Chronic Hepatitis B
9.Hypertension P IV
10.Parkinson's Disease P IV
11.Schizophrenia
Submission Launch
20202015 2016 2017 2018 2019Timeline
USA China
EU TW
Items
US$1.2B
US$55mmUS$35mm
US$215mm(德+荷+丹)
US$900m
US$130m
US$65m
US$350m
US$1.4B
US$170m
US$70mm
US$600m
US$400m
US$18mm
US$230m
US$250m
US$640m
Professionalism Honesty Decisiveness
Portfolio
Professionalism Honesty Decisiveness
We Offer…..
Pharmadax Inc - Company Presentation 14
Co-development and Marketing Partnerships
Regulated Market – CMO Opportunities – Tablets
Dossier development andTechnology transfer servicesfor Modified ReleaseProducts
Why PharmadaxWe believe in professionalism, we work with honestyand we perform decisively.
Quality and Compliance is our core ideology, which isexhibited in our products, people and partnerships.
THANK YOU
Pharmadax Inc - Company Presentation 15
For collaboration opportunities:[email protected] OR
Call: +886-2- 2223-1552
Corporate Office: Pharmadax Inc. 5F-1., No.236, LianchengRd., Zhonghe Dist., New Taipei City 235, Taiwan (R.O.C.)
PHARMADAXIMPROVING QUALITY OF LIFE