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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
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