BIOPHOREWe Focus on Niche APIs For

Generic Industry

ABOUT US

What We Do

Overview

R&D driven company

Focus on creating superior value

proposition

Providing end to end solutions

Manufacturing

Two world class facilities

Both USFDA approved

Wide range of therapeutic areas

Specialists

Development for Regulated markets-

US & EU

Development for PIV challenges

Core capabilities in complex

Injectables

Novel process and polymorph

development

Products and Pipeline

Over 40 DMFs filed

Over 80 APIs developed

Filed over 30 patents

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Beginnings Growth New Clients Awards

R&D center setup in

2007

First Manufacturing

facility started in 2010

Second Manufacturing

facility started in 2014

First USDMF filed in

2010

Sionc USFDA

approved in 2013

Azico-Biophore

USFDA approved in

2015

Third most USDMFs

filed worldwide in 2015

Recognized as one of

the fastest growing

pharma companies by

Silicon Review®

ABOUT US

Inception and Growth

40 DMFs filed by 2016

Currently catering to

over 85 customers

Several in top 20

pharma companies as

clients

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Our aim is to place Biophore in the midst of most reliable

knowledge based firms in the API sector in the immediate near-

future through customer-focused approachVision

To be the most trusted R & D company in the complex and niche

pharmaceutical molecule segments and achieve superior

customer satisfaction through continuous innovation; and

providing an inclusive work culture that helps our employees

excel and grow

ABOUT US

Vision and Mission

Mission

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OUR PRESENCE

Global

220 R&D StaffIn synthesis, analytical, formulation,

IP and regulatory

10 Member CQA teamTo monitor manufacturing and

compliance in two sites

US NJ OfficeFor front end marketing and

Regulatory submissions in USA

5 LocationsIncluding USA, Hyderabad,

Vishakhapatnam

600 PeopleIn manufacturing and

Research

Over 25 ProjectsIn development stage at any

point of time

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OUR STRENGTHS

Our

Accomplishments

40 DMFs Filed

Over 80 products developed

and several complex barrier

to entry products

successfully completed

30 Patents Filed

Over 40 DMFs filed in US,

EU and a few DMFs filed in

Canada, China, and Turkey

Over 30 patents filed in the

last 8 years and for a few

key products patents have

been filed globally

Over 50 product validations

executed in the

manufacturing facilities

Synthesis

and

Analytical

Intellectual

Property and

Management

Regulatory and

DMF filings

Execution and

Project

Management

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DMFs

Filing Growth

21

3

9

5

12

15

2

1

1

3

3

1

1

2

1

1

2

2

0

5

10

15

20

25

2010 2011 2012 2013 2014 2015 2016Planned

USDMFs

EUDMFs

Canada

DMFs

Other

DMFs

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OUR MANAGEMENT

Directors

Dr. Jagadeesh Rangisetty

CEO and Managing Director

Biophore

• M. Pharm. - BITS, Pilani

• Ph.D. - BITS, Pilani

• Post-Doc - VCU, Virginia, US

Dr. Manik Reddy

Chief Scientific Officer

Biophore

• Over 25 years of research experience

• More than 70 patents and publications

• Director of lab at VCU

• Was Vice-President and co-founder

of Navinta LLC, New Jersey

• B. Pharm. - BITS, Pilani

• Ph.D. - VCU, Virginia, USA

• Post-Doc - VCU, Virginia and UGA, Georgia

• Over 17 years of research experience

• More than 45 patents and publications

• Worked at Navinta LLC, New Jersey

• Worked at Hospira, Colorado

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OUR TEAM

Key People

K. Ramesh

COO

More than 30 years

experience in the industry.

Was head of Supply Chain at

DRL and was CEO of

Vijayasri Organics previously

Dr. M. Nandakumar

VP – R&D

Ph.D in organic chemistry

with post-doc experience

from US and Germany. Has

about 18 years of research

experience.

K. Kalyan

VP – ARD and Compliance

Is a post graduate in

analytical chemistry. Has

about 20 years experience in

Pharma and was previously

with Actavis and Cipla.

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OUR FACILITIES

R&D

Corporate

Office

Located in Jubilee

Hills, Hyderabad

Functions of

finance, IT and

Business

development

operate from here

Central

R&D Center

State of the Art

R&D center of

about 80,000 Sft.

will be operational

in July 2016

located in

Pashamylaram,

Hyderabad

Vizag R&D

Center

Located in Vizag

in Pharma city

and focusses on

process

development and

optimization

activities

ARD Center

GMP analytical

validation

activities are

performed at this

center and is

located in

Balanagar,

Hyderabad

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OUR FACILITIES

Sionc

Pharmaceuticals

Location and details

Located in Pharmacity Vizag

100% EOU unit

Operational since 2010

Capabilities and Setup

5 clean rooms in facility

Setup for both very small volume and

medium volume products

Also has Oncology manufacturing suite

Regulatory Status

USFDA approved in 2013

EU approved in 2015

CDSCO Written confirmation from 2014

DMFsOver 30 DMFs filed from the facility

About 40 products manufactured in the

facility

Supplying products commercially to US

and EU

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OUR FACILITIES

Azico-Biophore

Pharma

Location and details

Located in Pharmacity Vizag

Operational since 2014

Capabilities and Setup7 clean rooms in facility

Lyophilization and dialyzer capability

Peptide manufacturing facility

Dedicated hormonal products

manufacturing facility

Regulatory Status

USFDA approved in 2015

EU inspection in 2015 for Microbiology

lab

DMFs9 USDMFs filed from the facility in 2

years

About 18 products manufactured in the

facility

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Our Products

COMPLEX CHARACTERIZATION

Ferric citrate

Sucroferric Oxyhydroxide

Iron Sucrose

Sodium Ferricgluconate

Ferric Carboxymaltose

PRODUCT STATUS

Validations Complete

Under Validations

Developed

Developed

Under Development

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Iron Products

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LYOPHILIZED PRODUCTS

SBECD

Icatibant Acetate

Sincalide

Pasireotide

PRODUCT STATUS

DMF Ready

DMF Filed

Developed

Under Development

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Peptides and Excipients

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COLORED PRODUCTS

Isosulfan Blue

Indigo Carmine

Methylene Blue

Indocyanine Green

PRODUCT STATUS

DMF Filed

Under Validations

Developed

Under Development

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Dyes For Human Use

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HORMONAL PRODUCTS

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Synthetic APIs

Levothyroxine Sodium

Liothyronine Sodium

Esterified Estrogens

Conjugated Estrogens

PRODUCT STATUS

DMF Filed

Validations Complete

Developed

Under Development

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Under Validations

ONCOLOGY APIs

Orals and Injectables

Bendamustine

Melphalan HCl and Free Base

Decitabine

Bortezomib

Clofarabine

Chlorambucil

Nilutamide

Carfilzomib

DESCRIPTION DMF

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CONTRAST AGENTS

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MRI and Radio-contrast

PRODUCT STATUS

DMF Filed

Validations Complete

Developed

Under Development

DMF Filed

DMF Filed

DOTA

DTPA

Gadobutrol

Gadoxetate

Diatrizoate Sodium

Diatrizoate Meglumine

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NCE-1 PIPELINE

PRODUCT

Tavabarole

Belinostat

Palbociclib

Pasireotide

Pirfenidone

Ferric citrate

STATUS

Developed

Developed

Under Development

Under Development

Developed

DMF Ready

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Thank you

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