Ascent Innovative Medicines Pvt. Ltd.

A 327, Road No. 25/34, Wagle Estate,

Thane, Maharashtra, India - 400604

An Integrated Drug Development Solutions Provider Established by experienced pharmaceutical professionals with global exposure.

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Ascent is a Pharmaceutical Research and Development company with innovation at its core

Striving to be Global leader in

Pharmaceutical Drug Development Founded in 2016 in Thane, Maharashtra, India

Total employees (June 2017) 41

• Formulation 10

• Analytical D 18

• Marketing & Sales 02

• Support Functions 09

Impressive 15 drugs in development within one year of Operations

Privately Held, Investors with deep interests and investments in Pharma domain

No external borrowing or debt

Founder Dr SB Roy, PhD MBA, more than 35 yrs in the industry

Drive innovation forward

Pursue top quality science, internally

and externally, balanced with medical

need and commercial potential

Practice highest standards of ethics

Quality, Confidentiality, Data Protection

is crucial and ingrained across all

functions in all we do

Add Global Clientele

Expand innovative commercial

capabilities to new customers and

regions. Manage alliances putting the

product first

Four Goals for Ascent

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Maximize the value of innovation

Develop projects ourselves and seek

partners or out-license when necessary

to maximize value

Ascent’s strategy and advantages

Low cost drug development and technology transfer

Team filing experience of more than 400+ formulations across various dosage forms

Team Track-record of successful drug development and commercialization in major

markets

Use internal accrual revenues in the funding of drug development and commercial

expansion

Investors history of astute capital management coupled with real-world experience in

pharma healthcare and proven customer insights

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New Products - Generics, Specialty (Novel Drug Delivery)

Reformulation

Life Cycle Extension of existing molecules

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>35 years of rich experience in pharmaceutical industry

Ranbaxy, Sandoz, Astra, Warner and Zydus Cadila

Enabled companies to develop cost effective drugs and

generate a global footprint

Directed development of various dosage forms for

regulated markets- USFDA, MHRA, EMA, ANVISA, Japan,

TGA etc

Developed viable portfolio of products across a range of

generic and differentiated formulations.

Development, registration and commercialization of novel,

value creating medicines that improve patients’ lives.

Developed a robust pipeline in various therapeutic

segments.

Registrations in

+ 60 countries

US

Japan

EU: France, UK, Spain, Denmark & Latvia

LATAM: Brazil & Mexico

Russia, Ukraine, Belarus, Uzbek & Kazakhstan

Middle East : UAE Dubai, Kuwait & Oman

Africa - South Africa, Uganda, Kenya, Nigeria, Ethiopia & Ghana

Asia Pacific - Sri Lanka, Malaysia, Philippines, Taiwan, Singapore, Myanmar & Vietnam

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Generic Pharma Leadership Outcome

Significantly Low cost to filing per product √

Significantly low Manpower to filing ratio √

Exponential increase in filings √

Time to develop and register a generic drug

(includes several first to files and block busters) √

Introduction of multitude of dosage forms √ Benefit from Ascent’s experienced leadership and

management

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Dr. S B Roy CEO & Director

Accounts

Plant Head

Business

Development

Analytical

Development

Packaging

Development

Intellectual Property Business

Development,

Planning &

Sourcing

Formulation

Development

Quality Assurance

Regulatory

HR &

Administration

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Cumulatively 200+ years of Technical Team Experience

Flexible and nimble to client needs

Blend of experience with advanced degrees in pharmaceutical sciences

90% of the team with post graduate qualifications

Agile team with a rich experience in honoring client deliverables

Worked across Indian and Western Multinational Generic Companies

Rich experience across entire Development value chain - IP, Preformulation,

Formulation, Analytical Method Development, Validation, Pharmacokinetic,

Packaging, Manufacturing, Clinical Research and Development

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Product development CMO Regulatory

• RLD Selection • Development Plan

strategy • IP assessment • API Vendor selection • API DMF gap analysis • Review and

finalization of development documents

• Site selection for commercial batches

• Support to CMO for Tech transfer

• Exhibit batches (BMR, MFR,BPR)

• 6M Stability data from exhibit batches

• Process Validation • Successful BE

outcomes

• Patent/Exclusivity time frame

• Product Labelling • Dossier

Compilation & Filing

• Compliance review of regulatory documents

• e-CTD Submission

Fully Integrated or Standalone

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Development only OR

Development + Supplies Models

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Pharmacopoeia Merck Index Florey Vidal Orange Book

Literature search

Active Sourcing Active

Evaluation Active Purchasing

and Testing DMF

Innovator Product Purchasing and

Testing

Bulk Active Testing and VQ

Excipient Selection and

Testing

Formulation and Analytical Method

Development

Manufacturing Process Evaluation

Container Closure Evaluation

IP Clearance Process Optimization

Report Analytical Method Transfer Report

Pilot Stability and BE study

Finished Product Specification

TT Documents Scale Up/ Pre

registration batches

Process Qualification BMR and BPR

Registration Batches Production

An Integrated Drug Development Solutions Provider Established by experienced pharmaceutical professionals with global exposure.

25/07/2017

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