A Presentation On The Development of Pharmaceuticals Industry In Vietnam

PowerPoint Presentation Synergizing the global expertise of PharmSol and Chempro for the benefit of Vietnam Pharma Future Plans of Our Vietnam Office A Presentation On The Development of Pharmaceuti.

A Presentatio

n On The Development of Pharmaceuticals Industry

In Vietnam (All Types of Finished Dosage Forms including

Through their Joint Office in Vietnam

Bring To Vietnam Smart Products , Bespoke Solutions

For the Pharmaceuticals and Biosimilars Sector

To Ensure Regulatory And

Commercial Competitiveness For

A Sustained Profitable Growth Of Business

Internationally while simultaneously empowering the Vietnamese Industry to manufacture greater number of

products locally through technology transfers

33+ 40+ 7+ 5+ 16+ 11+

Accreditations

Include

WHOGMP/

EUGMP/

USFDA/

PMDA/

KFDA

Country-

India

Committed to the Pursuit of

Excellence and Development of

Pharmaceuticals Industry in

Vietnam through Development of

Smart & Quality Products,

Providing Ongoing Expert Solutions

to meet the needs of Vietnamese

Pharma and Biotech Industries

thereby ensuring their sustained

commercial competence globally

while simultaneously empowering

them for imports substitution.

To be One of the Worlds’ Leading and Most Reliable Products & Solutions Partners WhFo Ensure Global Competitiveness of Our Clients on a Sustained

Basis By Providing Solutions to all problems relating to Pharmaceuticals Production under one Roof

Global Presence

Strengths & Offerings

Cooperation Models

Licensing & Supply Contract Development & Manufacturing

Co-developments Tech Transfers

• Supply of Human APIs & Finished Formulations from India.

• Supply of API Intermediates up to (n - 1) from India.

• Custom Synthesis of Fine & Specialty Chemicals.

• Supply of Reference Standards of APIs/Impurities for testing.

• Supply of Veterinary APIs & Finished Formulations.

• Process Technology Outsourcing.

Strengths & Offerings

• Research & Development Outsourcing.

• Regulatory Support Services for Dossier Compilation in CTD/ACTD/EUCTD format/Bio Equivalence Studies/Clinical Trials.

• Cargo Consolidation (GDP certified facilities and employees) & Pre-Shipment Sampling.

• Just-In-Time Inventory Management.

• Overseas Stock Arrangements.

• Trusted Value Chain Partner.

Strengths & Offerings

• We manufacture our own critical raw materials.

• We have strategic tie-ups with foreign raw material suppliers.

• We possess critical purification technologies developed to reduce or eliminate isomer formation.

• We also have other solvent purification and recovery systems in place We

conduct efficient in-process testing for various raw material stages.

Strengths & Offerings

Track Record

t Teams

Sunil Doshi

Founder & Managing Director

36 Years of Global Techno-commercial

Expertise in Pharma Industry

S Lakshminarasimhan

Chief Operating Officer

25 Years of Pharma Technology, Compliance & Regulatory

“Leading a global team of 80 committed professionals.”

Senior Scientific Adviser

35 years of expertise in Biotech, Biosimilars & Regulatory

Andrej Gasperlin

Senior Business Associate - US

35 years in US Pharma Business

Arun Sehgal

Director – Strategic Business

40 years of expertise in Pharma Business and Management

Strategy Team

Director –Regulatory Affairs

40 years of USFDA Compliance &

Regulatory expertise

Ashish Dasgupta

Senior Scientific Adviser

40 years of expertise in Clinical, Quality & Regulatory

Ganesh Sangaiah

Director – NDDS

26 years of expertise in NDDS

Accreditations

Some of Our Esteemed Clients…

Our Leadership Team

Arun Sehgal- CMD Vijay Agarwal- CEO Deep Khanwalkar- Director Sunil Doshi- Director

Shubhit Sehgal- Director Vandan Agarwal- Director Abhishek Khanwalkar- Director Vishal Agarwal- Director

Some of Our Esteemed Clients…

Developing Global Business Competencies

of Our Strategic Vietnamese Partners

Through 6 Steps

1 Technology Transfers by bringing in the Best Talent

2 Regulatory Audits by our in-house Team of Experts and

3 Regular Cost Competency Audits

by Our Team of Global Supply Chain Experts to

4 Develop Efficient and Competitive Supply Chains of Manufacturers

who are preferably audited by us to Ensure Availability of

5 Just-In-Time Raw Material Inventories and facilitating

6 Product Registrations in the EU

Our Competencies Building Strategy

In Our Vietnamese Partners - 6 Steps

Proposed Business Model

Raw Material

Supplier

Vietnamese Manufacturing Partner

EU Registrations

Audits & Just- In-Time Inventory Arrangement

s

Regular

Costing Audits

Regular Regulatory Audits &

Technolog

y Transfer

Regular Regulator

y Audits

MAs

in EU

Will Also Help Inclusion Of Local Manufacturers in Group 1 For Domestic Tenders

Synergy to the Advantage

of Vietnam Pharma

Combined Strengths…

PharmSol

• 50(+) years of Cumulative experience of the Founders

• Rich Experience of Developing, Registering,

Marketing Generics in EU (including 20+ First to File)

• Expertise in the areas of Manufacturing, Technology,

Compliance, Regulatory and Marketing

• Offering innovative, comprehensive, tailored

Solutions for every aspects of Pharma Value Chain

• Cost competitive and time efficient Turnkey

Projects

• Strong team of 75+ technocrats and growing…

• Association with the renowned Industry Experts in

the field of Pharma, Biosimilars, Clinical

Chempro

80(+) years of Cumulative experience of the Founders

Rich Experience of Developing Innovative New

Molecules (including 36+ First from India)

Expertise in the areas of Manufacturing, Technology, Supply Chain Development and Marketing

Offering innovative, comprehensive, tailored Solutions for Value Creation in the Pharma Supply Chain

Expertise in Designing Cost competitive Business Architectures to build Global CompetitivenessStrong Domestic and International network of experts

Overseas Stock Locations for Just-In-Time Inventories

Our Contribution to Vietnam

Pharma

Empowering the Vietnam pharma industry to achieve a sustained profitable growth by:

• Enabling Local Manufacturing

• Providing Global Market Access

Bringing Best of the Pharma World to Vietnam…

&

Introducing Vietnam Pharma to the World…

How We Support…

• Tech Transfer of Efficient and Cost Competitive Formulation Technologies

• Building a reliable Supply Chain of APIs

• EUGMP & Other Certifications for Vietnam based Facilities

• Registering Vietnam manufactured Finished Products in Global Markets

• Implementing Marketing Strategies and generating a sustained stream of Export Revenue

• Helping Vietnam Fast-forward into Biopharmaceuticals

• In-licensing

• Local Development

Cost Competitiveness

• Regular Cost Competency

Audits vis-à-vis competition

Market Access

• Product Registrations

• MA Holding

• Batch Testing/Batch Release

• Finding, Liaising and finalizing the deal with Marketing / Distribution partner

• Commercial Supply Chain Management

• Post Marketing Follow up

How We Support…

• Making Vietnam Pharma globally competitive

• Raising the bar of GMP Compliance provides opportunities to Manufacture & Supply to the Regulated Markets

• Getting an EU MA will help companies fall in Group 1 or increase the chances of commanding higher prices in Vietnam tenders

• Biopharmaceuticals – bringing the best available expertise which will help

Vietnam Pharma

• Creating Biosimilars development capabilities

• Setting up manufacturing with higher standards of Quality &

Compliance

• Compressing the lead time from Concept to Commercialization

Advantage – Vietnam Pharma

Thank You!