Hetero Access Expect more From Life

Namibia

Access = Hope

Reach + Range

Robust Pipeline

We are Hetero

Hetero was founded in the year 1993, by the visionary scientist Dr. BPS Reddy. Under his leadership, Hetero has risen to become the largest closely held pharmaceutical company in India and a world leader in the production of anti-retroviral drugs.

Content

We are Hetero

Hetero was founded in the year 1993, by the visionary scientist Dr. BPS Reddy. Under his leadership, Hetero has risen to become the largest closely held pharmaceutical company in India and a world leader in the production of anti-retroviral drugs.

HETERO’S HISTORY IN THE MAKING

Our first API manufacturing facility

at Hyderabad began its operations

Established state-of- the-art R&D centre

– Hetero Research Foundation (HRF)

Emergence as one of the first Indian

companies offering affordable ARV APIs

HRF recognized for developing processes

for about 20 APIs within 3 years

First US FDA approval for API manufacturing

facility at Hyderabad, India

One of the first companies to develop lifesaving

drug ‘Oseltamivir’ for Bird Flu and Swine Flu

US FDA approval for finished dosage

manufacturing facility at Hyderabad, India

Established Asia’s largest manufacturing complex

for APIs in Vizag, India

Established a dedicated facility to manufacture oncology

injectables in Hyderabad, India

Established world class Biologics

unit in Hyderabad, India

Launched the blockbuster Hepatitis C drug ‘Sofosbuvir’ under in-licensing deal

Launched our first biosimilar product ‘Darbapoetin alfa’

Launched our second biosimilar product ‘Rituximab’ in India. Became the first company in India to launch the fixed-dose

combination ‘Ledipasvir+Sofosbuvir’ Launched the generic drug ‘Daclatasvir’

Launched our third biosimilar product ‘Bevacizumab’ in India

National Award for Best efforts in

Research and Development Made first foray into US generic market with

Zidovudine Tablets

1994

1995

1996

1997

1998

2001

2005

2006

2007

2008

2009

2014

2015

2016

20+ years of expertise in pharmaceuticals

Amongst the world’s largest manufacturers of API

25+ state-of-the-art manufacturing facilities

Global presence of 120+ countries

15,000+ employees worldwide

200+ products in portfolio

India’s largest closely held pharmaceutical company

ANNUAL PRODUCTION CAPACITIES

Formulations

Tablets

45

billion units

Capsules

6.7 billion units

Liquids

20 million units

Pellets

360

tones

Injectables

181

million units (includes lyophilised,

liquid & powder)

Finished formulations facility, Hyderabad, India

CORE VALUES THAT DEFINE HETERO

Entrepreneurship

We derive our strength from the

Entrepreneurial Spirit

of our team members.

Knowledge

We recognize, cultivate and

nourish Knowledge as the key driver in

providing healthcare at affordable cost.

Quality

We demonstrate Quality and continuous

improvement in every aspect of our

practices.

We are Dynamic and passionate in our

approach to

customers and our business.

Caring

We are committed to Caring for humanity and

environment, as a responsible

member of the global family.

Dynamism

OUR KEY THERAPIES

PIONEERING RESEARCH & DRIVING DEVELOPMENT

Focused on developing quality products, with special emphasis on their safety and efficacy

Excellent infrastructure

Expertise spans across formulation, analytical, packaging, IP, technology transfer, and quality assurance

Inspiring the development of innovative, safe, environment-friendly and cost-effective processes to deliver high-quality products

Continued investments in new areas of research such as biosimilars and exploration of new technology platforms

Hetero’s Global Presence

Countries with Regional Offices

India, USA, Brazil, Mexico, Colombia,

Russia, Spain, Poland, Dubai,

Singapore, Thailand, Philippines,

China, Egypt, South Africa, Ukraine,

Argentina, Algeria, Chile and Nigeria

Regional Office

Through agents

Sun doesn’t set in Hetero’s plants

Countries with

Manufacturing Plants

INDIA CHINA

INDONESIA EGYPT

RUSSIA

MEXICO

USA

Access = Hope

Hetero is o e of the orld’s largest produ er of a ti-retroviral (ARV) finished formulations and APIs. The

o pa y’s o it e t to ards HIV/AIDS treat e t started way back in 1997 and soon transformed it into a

leading supplier of affordable APIs for anti-retroviral

finished formulations.

Hetero Access

Strong portfolio of over 30 ARV combinations

One of the global leaders in ARVs

Catering to 4.3 million HIV/AIDS patients globally*

A leading supplier of ARV APIs to several finished dosage pharmaceutical companies

A commitment towards HIV/AIDS since 1997

* Yr 2015-16, Either in API or FDF

Customer Specific Access Teams

NGO’s • Dedicated team for TGF

SCMS, UNICEF, PAHO, for global tenders

In- Country

• In –country specific team for the Country ARV need

Wholesalers

• Catering IDA, IMRES, MEG etc. being catered by single window

Centrally Handled by the Access Team

Africa : Pan presence + Access to ARV’s

• Deli eri g life sa i g ARV’s to Afri a si e 2001

• Supplyi g ARV’s a ross the o ti e t either dire tly or y Global Funding bodies

• A ti e registratio of ore tha 3 ARV’s a ross the continent

• Supporting Dream project in Eastern and Western Africa

• Continuously working for the upgradation of HIV/AIDS

management in Medical fraternity

• One of the few companies to make ARV Solution for Ped.

HIV management

Presence through

Agents

On ground presence

Capacity

In order to match the upcoming

demand of ARVs and 90:90:90 we

are in a process of adding

another FDF plant .

Reach

Pipeline Registration

Improvement Planned for a Better Tomorrow

Increasing our reach in CIS,

LATAM and South East Asian

countries

Have submitted another 690+

new dossiers to different

countries.

A robust ARV pipeline and future

ready. Working on DTG and TAF

based STRs.

Reach + Range

Therapies we cover

Access

ARV O er 3 + SKU’s

SRA approved

In 2015-16, almost 4.3 Million HIV positive patients were on our ARV*

Hep-B/C Tenofovir,

Entecavir & DAA

Registered Sofosbuvir to more than 20 countries and 2000+ patients were on

our Hep C regimen

Anti- TB

Linezolid, Moxifloxacin, Cycloserine & Levofloxacin

One of the largest supplier of SRA approved Linezolid for Stop TB

program

Anti - Malarial

Artesunate, Artemether and

combinations

In Pipeline (will make available in African and Asian countries at

affordable rates)

ARV Product List : First Line

Sl.No Product Name Pack Size

Regulatory Status

Approval Status WHO Approval Status

USFDA

1 Tenofovir/Efavirenz/Emtricitabine Tablets, 300 mg/600 mg/200 mg 30's Approved Approved

2 Tenofovir/Efavirenz/Lamivudine Tablets, 300 mg/600 mg/300 mg 30's Approved Approved

3 Tenofovir/Lamivudine/Nevirapine 300 mg/300 mg/200 mg (kit) 30's + 60's --- Approved

4 Lamivudine/Zidovudine/Nevirapine Tablets, 150 mg/300 mg /200 mg 6 ’s Approved Approved

5 Emtricitabine/Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg 3 ’s Approved Approved

6 Tenofovir DF/Lamivudine Tablets, 300 mg/ 300 mg 3 ’s Approved Approved

7 Abacavir sulfate/Lamivudine Tablets, 600mg /300mg 30's Approval Pending Approved

8 Zidovudine/Lamivudine Tablets, 300 mg/150 mg 6 ’s Approved Approved

9 Tenofovir Tablets, 300 mg 3 ’s Approved Approved

10 Abacavir Tablets, 300 mg 6 ’s Approved Approved

11 Efavirenz Tablets, 600 mg 3 ’s Approved Approved

12 Nevirapine Tablets, 200 mg 6 ’s Approved Approved

13 Zidovudine Tablets, 300 mg 6 ’s Approved Approved

14 Lamivudine Tablets, 150 mg 6 ’s Approved Approved

ARV Product List : Second Line

Sl. No Product Name Pack Size

Regulatory Status

Approval Status WHO Approval Status

USFDA

Protease Inhibitor

17 Lopinavir/Ritonavir Tablets, 200 mg/ 50 mg 120's Approved Approved

18 Darunavir Tablets 400 mg & 600 mg 60's --- Approved

19 Ritonavir Tablets 100mg 60's Approved Approved

20 Atazanavir Sulfate and Ritonavir Tablets 300mg/100mg 30's Approval Pending

Integrase Inhibitor

21 Raltegravir Tablets, 400 mg 60's --- Approved

PEDIATRIC ARVs

22 Zidovudine Oral Solution 50mg/5ml 240 ml Approved ---

23 Lamivudine Oral Solution 10 mg/ml 240 ml --- Approved

24 Abacavir Oral Solution, 20 mg/ml 240 ml Approved Approved

25 Abacavir/Lamivudine Tablets, 60 mg /30 mg 30's --- Approved

26 Lopinavir and Ritonavir Tablets 100/25 mg 120's Approval Pending Approved

27 Tenofovir DF/Lamivudine Tablets, 75 mg/ 75 mg 30’s Approval Pending Approved

Hep C and Hep B Range

One of the first companies to

launch Hepatitis C drug –

Sofosbuvir in the Indian market.

Through our JV with Pharmed

healthcare in Egypt for local

manufacturing we have entered the

largest Hepatitis C market in the world.

Our Direct Acting Antivirals are now

registered and used in more than 20

countries

Vertically integrated & major suppliers

of Hep C regimen's APIs and FDFs

Committed to ensure high standards of

quality, safety and efficacy by virtue of WHO

PQ for current and pipeline products

Product WHO PQ status

1. Sofosbuvir Tablets Submitted for SRA approval

2. Sofosbuvir + Ledipasvir Under Planning (Sept. 2017)

3. Daclatasvir Tablets Under Planning (Oct. 2017)

4. Sofosbuvir + Velpatasvir Under planning (July 2018)

5. Tenofovir SRA Approved

6. Entacavir SRA approved

Anti-TB Range

• Major supplier of Linezolid, Moxifloxacin, Levofloxacin for the Stop-TB programs in the developing world

• Seeking opportunities for development of Sutezolid and dispersible MDR Anti TB drugs for Ped. Patients.

• HIV- TB: Working for the development of Rifabutin which is lower drug- drug Interaction with PI, DTG and EFV

Keeping in pace with UN AIDS 90-90-90 vision, we aim to reach out to

10 million patient globally with our ARV’s by 2020

Expect

More

From

Life

Reaching 10 million

patient in 2020

With an experience of

20 years of ARV

management

Robust Pipeline

ARV Working on next generation NNRTI free STRs

for both Adult and Ped dosages

Hep-B/C Working for Pan Genotypic regimen to

avoid the expensive genotypic test

Anti- TB Focusing on MDR and XDR TB and Rifabutin

for HIV-TB co-infection patients

Anti - Malarial Reducing the pill burden by making

palata le STR’s

ARV pipeline

TAF

25 mg

TAF/FTC

25/200 mg

TDF/FTC/ DTG

300/200/50 mg

TDF/3TC/ DTG

300/300/50 mg

DTG

10, 25, 50 mg

TAF/ 3TC/DTG

25/300/50 mg

TAF/ FTC/DTG

25/200/50 mg

LPV/RTV/ABC/3TC

40/10/60/30 mg

ABC/3TC/DTG Ped.

60/30/5 mg

ABC/3TC/EFV Ped.

150/75/150 mg

01

03

05

07

09

02

04

06

08

10

* These 10 are the focused ARV development, apart from

that we are also working for other developmental projects

Access for All

Focused Pediatric Formulations

• Abacavir 60 mg/Lamivudine 30 mg/Dolutegravir 5 mg Dispersible Tablets

• Lopinavir 40 mg/Ritonavir 10 mg Oral Pellets

• Abacavir 150 mg/Lamivudine 75 mg/Efavirenz 150 mg Dispersible Tablets

• Abacavir Sulfate 60 mg/Lamivudine 30 mg Dispersible Tablets

Working on Solid dosages form for the Ped. Patients as it will helpful for

• Ease of Dosing

• Accuracy of Dosing

• No wastages of Drug

• Convenient for dosing

• Increase Compliance

A Better Tomorrow

• Removing the carton and providing less number of pack- insert to reduce the paper wastages

• Reduce the weight of the shipment

Reduced Packaging

• Pa k of 9 ’s or ’s ta lets for STR’s • Optimize ART center visit for patients

Bulk Packaging

• Solid dosages formulations for Pediatric patients NDDS

NAMIBIA

We are here to Strengthen Namibia’s

fight against HIV/AIDS

Total HIV Population in Namibia

~210 000

Adults aged 15 and over living with HIV

~200 000

Children aged 0 to 14 living with HIV

~10 000

A Novel Initiation of

Test and Treat

Strategy will help

better HIV

management

Reference :HIV and AIDS estimates 2015, UNAIDS

Ready for tomorrow

Quality

Reliability

Local Collaboration

Collaborated with

COSPHARM for Marketing in

Namibia

SRA Appro ed ARV’s ith fo used approa h o STR’s and next generation drugs

We are Vertically

Integrated for

ARV with more

than 20+ years

of experience in

Africa

THANK YOU

access@heterodrugs.com

www.heteroworld.com