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

World class EU approved solid oral

manufacturing facility

Specialists

Development for Regulated markets and

PIV challenges

Core capabilities in complex APIs,

polymorph development and Injectables

Consistently in Top 10 DMF filers in last 4

years

Products and Pipeline

Over 70 DMFs filed

Over 100 APIs developed

Filed over 80 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

Third Manufacturing

facility shall be

commissioned in 2018

First USDMF filed in

2010

Sionc USFDA

approved in 2013 and

2016

Azico-Biophore USFDA

approved in 2015 and

2018

Third most USDMFs

filer worldwide in 2015

Recognized as one of

the fastest growing

pharma companies by

Silicon Review®

Recognised as India’s

Small Giants by MSME

Forum Govt of India

ABOUT US

Inception and Growth

Currently catering to

over 130 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

approach

Vision

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

300 R&D StaffIn synthesis, analytical, formulation,

IP and regulatory

US NJ OfficeFor front end marketing and

Regulatory submissions in USA

5 LocationsIncluding USA, Hyderabad,

Vishakhapatnam

1000 PeopleIn manufacturing and

Research

Over 25 ProjectsIn development stage at any

point of time

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Zenara PharmaDedicated world-class solid orals

manufacturing facility

OUR STRENGTHS

Our

Accomplishments

70 DMFs Filed

Over 100 products

developed and several

complex barrier to entry

products successfully

completed

80 Patents Filed

Over 70 DMFs filed in US,

EU and a few DMFs filed in

Canada, China, and Turkey

Over 80 patents filed in the

last 10 years and for a few

key products patents have

been filed globally

Over 80 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

2 13

9

5

1210 10

3

2

1

1

3

4

8

3

1

11

1

1

1

22

8

1

0

5

10

15

20

25

30

2010 2011 2012 2013 2014 2015 2016 2017 2018

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 27 years of research experience

• More than 80 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 18 years of research experience

• More than 70 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. Bhaskar Reddy

AVP – R&D

Ph.D in organic

chemistry with post-doc

experience from US. Has

about 15 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.

Pashamylaram,

Hyderabad

Vizag R&D

Center

Located in Vizag

in Pharma city

and focusses on

process

development

and

optimization

activities

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Zenara

PharmaCherlapalli,

Hyderabad

Specializes in

solid oral

formulation

manufacturing

OUR FACILITIES

Zenara

Pharmaceuticals

Location and details

Located in Cherlapalli, Hyderabad

Specialized in solid orals

Acquired in 2017

Capabilities and SetupMulti product manufacturing

capability

800 million units/annum capacity

Specialized in Capsules, Tablets,

gums and lozenges

Regulatory Status

EU GMP certified facility

Successfully inspected by the

ZAZIBONA, DHMA, DCA

Formulations

Capsules, Tablets (IR, ER, Bilayered)

Taste masking technologies

Medicated chewing gums

Pioneers in Nicotine gums

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OUR FACILITIES

Sionc

Pharmaceuticals

Location and details

Located in Pharmacity

Vizag

100% EOU unit

Operational since 2010

Capabilities and Setup

7 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 and 2016

EU approved in 2015 and 2018

CDSCO Written confirmation from

2014

DMFs

Over 40 DMFs filed from the facility

About 50 products manufactured in

the facility

Commercial supplies 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 Setup

7 clean rooms in facility

Lyophilization and dialyzer capability

Peptide manufacturing facility

Dedicated hormonal products

manufacturing facility

Regulatory Status

USFDA approved in 2015 and 2018

EU inspection in 2015 for

Microbiology lab

DMFs

20 DMFs filed from the facility in 2

years

About 30 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

DMF Filed

Under Validations

Under Validations

Under Development

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

Under Validations

Developed

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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

DMF Filed

DMF Ready

Developed

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Dyes For Human Use

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HORMONAL PRODUCTS

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Synthetic APIs

Levothyroxine Sodium

Liothyronine Sodium

PRODUCT STATUS

DMF Filed

DMF Filed

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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

DMF Filed

Under Validations

Under Validations

DMF Filed

DMF Filed

DOTA

DTPA

Gadobutrol

Gadoxetate

Diatrizoate Sodium

Diatrizoate Meglumine

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NCE-1 PIPELINE

PRODUCT

Tavabarole

Belinostat

Palbociclib

Pasireotide

Eliglustat

Ferric citrate

STATUS

DMF Filed

DMF Filed

DMF Filed

Developed

DMF Filed

DMF Filed

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Thank you

www.biophore.com