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2014
WHO Prequalified
Vaccines in Asia
All information is obtained from our partners or retrieved from the internet. Produced by
PREFACE
As our 5th Annual Vaccine World Summit India 2015 fast approaches,
IMAPAC Singapore has highlighted 13 Vaccine Manufacturers in Asia
with WHO-prequalified vaccines, correct as of 12 February 2015. We have
compiled the key information about these vaccines along with the detailed
profiles of each vaccine manufacturer for your interest and discussion.
The ranking is in no particular order and listed alphabetically
The content of this e-Book only represents the opinions of
IMAPAC
All information is provided by our partners or retrieved from
Internet
The vaccine and dosage information provided below is profiled
from the WHO-prequalified vaccines list [correct as of 21st November 2014]
CONTENT
3
4
5
6
7
8
9
10
11
12
13
14
15
Shanta Biotechnics
Serum Institute of India Ltd
Panacea Biotech
Biological E Limited
Haffkine Pharmaceutical Corporation
Zydus Cadila
Berna Biotech Korea Corporation
LF Life Sciences
Green Cross Corporation
Japan BCD Laboratory
GPO-MPB Government Pharmaceutical Organization
PT Bio Farma
Chengdu Institute of Biological Products Co. Ltd
2
SHANTA BIOTECHNICS
INDIA
PROFILE:
The genesis of Shantha Biotechnics Ltd
can be traced back to the initiatives of
Dr. K I Varaprasad Reddy and Mr. Khalil
Ahmed; Dr. Varaprasad and Mr. Khalil
Ahmed established the company in 1993
with the sole purpose of developing
efficacious but cost effective vaccines
and therapeutics within the reach of the
common man.
The project began modestly as an R&D
outfit at the Osmania University under
the industry-university interactive programme in 1993 and later at the Center
for Cellular and Molecular Biology until
an independent R&D facility was built.
In 2009, French pharma major Sanofi
vaccine division Sanofi Pasteur has
acquired Hyderabad-based Shantha
Biotechnics, which has been valued at
euro 550 million (over Rs 3,770 crore).
WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Cholera
1 dose Vial
Diphtheria-TetanusPertussis (whole Cell)Hepatitis B-Haemophilus
Influenzae Type B
10 dose Vial
Hepatitis BT
2 (paediatric) or 1
(adult) dose Vial
10 dose Vial
1 paediatric dose
Vial
6 dose Vial
20 dose Vial
Tetanus Toxoid
20 dose Vial
10 dose Vial
1 dose Vial
Shantha Biotechnic Limited (Shantha)
was acquired by Sanofi in July, 2009.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to
improve the quality of life for the public at
large.
CONTACT:
3rd & 4th Floor, H.No: 5-10-173, Fateh Maidan Road, Basheerbagh, Hyderabad – 500004
Tel: +91-66301000 | Email: [email protected] | Website: www.shanthabiotech.com
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www.imapac.com/business_conference/vwsi2015
3
SERUM INSTITUTE OF INDIA LTD
INDIA
WHO PRE-QUALIFIED VACCINE
PROFILE:
Serum Institute of India was founded in 1966
with the aim of manufacturing life-saving
immunobiologicals,which were in shortage
in the country and imported at high prices.
Thereafter, several lifesaving biologicals
were manufactured at prices affordable to
the common man and in abundance, with the
result that the country was made self-sufficient for Tetanus Anti-toxin and Anti-snake
Venom serum, followed by DTP(Diphtheria,
Tetanus and Pertussis) group of Vaccines
and then later on MMR(Measles, Mumps
and Rubella) group of vaccines.
The Philanthropic philosophy of the
company still not only exists but has been
proliferated to bring down the prices of
newer vaccines such as Hepatitis-B
vaccine, Rabies vaccine, Combination
vaccine etc., so that not only Indian’s, but
the entire under-privileged children of the
world, in more than 140 countries are
protected from birth onwards.
CONTACT:
212/2, Hadapsar,
Off Soli Poonawalla Road, Pune-411028, India
Tel: +91-20-26993900
Email: [email protected]
Website: www.seruminstitute.com
BCG
10 dose vial
20 dose vial
Diphtheria-Tetanus
10 dose vial
20 dose vial
1 dose ampoule
Diphtheria-Tetanus (for adults)
1 dose ampoule
10 dose vial
20 dose vial
Diphtheria-Tetanus-Pertussis
(whole cell)
1 dose ampoule
10 dose vial
20 dose vial
(whole cell)-Haemophilus
Influenza E Type B
1 dose vial + ampoule
(whole cell)-Hepatitis B
1 dose ampoule
20 dose vial
10 dose vial
(whole cell)-Hepatitis BHaemophilus Influenza E Type B
(liquid/lyophilised combination)
2 dose vial
10 dose vial
10 dose vial + vial
1 dose vial
Haemophilus Influenza E Type B
1 dose vial
Hepatitis B
1 adult dose ampoule
or vial
10 paediatric dose vial
1 paediatric dose
ampoule or vial
10 dose adult vial
Influenza A (H1N1) - Pandemic
5 dose vial
1 dose vial
Measles
10 dose vial
1 dose vial
2 dose vial
5 dose vial
Measles and Rubella
10 dose vial
5 dose vial
1 dose vial
2 dose vial
Measles, Mumps and Rubella
10 dose vial
2 dose vial
5 dose vial
1 dose vial
Meningococcal A Conjugate 5 mcg/dose
Meningococcal A Conjugate 10 mcg/dose
10 dose vial
10 dose vial
Polio Vaccine - Oral (OPV) Bivalent
Types 1 and 3
10 dose vial
20 dose vial
Polio Vaccine - Oral (OPV) Trivalent
10 dose vial
20 dose vial
Rabies
1 dose vial
1 dose vial
2 dose vial
5 dose vial
10 dose vial
Rubella
Tetanus Toxoid
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WHO PRE-QUALIFIED
VACCINE DOSAGE
1 dose ampoule
10 dose vial
20 dose vial
4
PANACEA BIOTECH
INDIA
PROFILE:
Panacea Biotec is a proactive company and has always laid emphasis on innovation and quality.
To fulfil Panacea Biotec’s corporate mission “Innovation in Support of Life” they have steadily
expanded their infrastructure to include state-of-the-art Research and Development centers
and facilities complying with cGMP standards, linked together by strong Information
Technology backbone.
WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Diphtheria-TetanusPertussis (whole cell) Hepatitis B Haemophilus
Influenza E Type B
10 dose Vial
1 dose Vial
CONTACT:
B-1 Extn./ A-27, Mohan Co-op. Industrial Estate, Mathura Road, New Delhi -110044, INDIA
Tel: +91-11-26945270, 26974500, 41678000 | Email: [email protected]
Website: www.panacea-biotec.com
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www.imapac.com/business_conference/asia-choco-congress-2015
5
BIOLOGICAL E LIMITED
INDIA
WHO PRE-QUALIFIED
VACCINE DOSAGE
1 dose vial
10 dose vial
(whole cell)
10 doses
1 dose vial
(whole cell) - Hepatitis B Haemophilus Influenza E Type B
1 dose vial
1 dose vial (Fully liquid)
10 dose vial
10 dose vial (Fully liquid)
Japanese Encephalitis
1 dose vial
Tetanus Toxoid
1 dose vial
Toxoid 10 dose vial
20 dose vial
PROFILE:
Biological E Limited was established over
50 years ago. It is the first private sector
biological products company in India and
the first pharmaceuticals company in South
India. BE is also the pioneer in preventive
medicine.
Biological E Limited supplies most of the
essential and lifesaving drugs to Central and
State Government Hospitals, Public Sector
Undertakings, the Indian Armed Forces and
the domestic retail market. BE’s International
division provides globalaccess to high quality
innovative products and caters to the health
and well-being of people worldwide.
CONTACT:
Biological E. Limited, 18/1&3, Azamabad, Hyderabad - 500 020, A.P., India.
Tel: +91-40- 30213999 | Email: [email protected] | Website: www.biologicale.com/index.html
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6
HAFFKINE PHARMACEUTICAL CORPORATION
INDIA
PROFILE:
HBPCL is the pioneer in the production of ASVS in India and has been producing it since
1940. Even the lyophilized ASVS has been introduced by HBPCL in the country since
1945.
Earlier it used to be the largest manufacturer of ASVS in the country producing about 60 70% of the country’s total production. ASVS produced by HBPCL has even been exported
to neighboring countries through WHO and UNICEF. The ATS department has produced
over 4 lakh vials of ASVS during 1999-2000 and 2000-2001.
However due to various restrictions imposed by CPCSEA on the use of equines in production of antisera, the production of ASVS has considerably reduced from 2001-2002 and has
been producing about 1.5 lakh vials since last 4-5 years.In 1997, HBPCL was successful
in introducing Scorpion Venom Antiserum for the first time in India, which was specifically
developed to fulfill longstanding demand from Konkan region. Currently HBPCL is the only
manufacturer of the same in the Country.
WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Polio Vaccine - Oral
(OPV) Bivalent Types 1
and 3
20 dose vial
(OPV) Monovalent Type 1
20 dose vial
(OPV) Trivalent
20 dose vial
CONTACT:
Acharya Donde Marg, Parel, Mumbai, India
Tel: +91- 22 24129320-24129322 | Email: [email protected]
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7
ZYDUS CADILA
INDIA
PROFILE:
Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. Vaccine Technology Centre (VTC) is the Vaccine division of the Zydus Group.
VTC has two state-of-the-art R&D Centers, one located in Catania, Italy; and the
other in Ahmedabad, in the western part of India. Zydus Vaccine division has indigenously developed, manufactured and launched India’s first vaccine against H1N1
(Vaxiflu-S).
The Vaccine Division’s Rabies Vaccine Manufacturing facility has received WHO
pre-qualification, and is one of the largest Rabies manufacturing facility in India.
WHO
PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Rabies
1 dose vial
CONTACT:
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India
Tel: +91- 02717 664600 | Website: www.zyduscadila.com
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www.imapac.com/business_conference/asia-choco-congress-2015
7
8
BERNA BIOTECH KOREA CORPORATION
- A Crucell Company
KOREA
PROFILE:
Crucell is a pharmaceutical company
engaged in the field of biotechnology
that has as its goal the development,
production and distribution of products for the prevention of infectious
diseases worldwide, particularly
vaccines and antibodies.
Crucell is currently engaged in the
struggle to twelve major infectious
diseases with its baggage of
commercially available vaccines
in the pediatric, respiratory, and
vaccines for international.
CONTACT:
Songdo-dong 23, Harmony-ro 303beon-gil
Yeonsu-gun Incheon, 406-840, South Korea
Tel: 82 3 2290 8400
Fax: 82 3 2290 8409
Website: www.bernabiotech.co.kr
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WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Diphtheria-TetanusPertussis (whole cell) Hepatitis B Haemophilus
Influenza E Type B
1 dose vial
Hepatitis B
1 dose vial
1 dose vial
(thiomersal
free)
10 dose vial
9
LG LIFE SCIENCES
KOREA
PROFILE:
LG Life Sciences (LGLS) started as a Korean-based genetic engineering department in LG
Chemicals in 1981, and has invested steadily in the life sciences ever since. This effort has resulted in the commercialization of various biopharmaceuticals. These include interferon in 1989
(Intermax-gamma™) and 1992 (Intermaxalpha™), hepatitis B vaccine in 1992 (Euvax B™),
human growth hormone in 1993 (Eutropin™), degenerative arthritis treatment in 2005
(Hyruan Plus™), recombinant human follicle-stimulating hormone (rhFSH) in 2006 (Follitrope™), and sustained-release human growth hormone (SR-hGH) in 2007 (Declage™).
LG Life Sciences’ vision is to become a “top-tier life sciences company class new drugs.” To this
end, the next-generation quinolone antibiotic Factive™ was approved by the US Food and Drug
Administration (FDA) in 2003, and the human growth hormone Valtropin™ was approved by the
US FDA and the European Medicines Agency (EMEA) in 2007. LG Life Sciences is expanding
its strategic alliances and fostering its capabilities to identify candidate drugs for development.
(from interview with In Chul Kim, president and CEO, LG Life Sciences, by Asiabiotech.
WHO PRE-QUALIFIED
VACCINE DOSAGE
Diphtheria-Tetanus-Pertussis (whole
cell)-Hepatitis B-Haemophilus Influenza
E Type B
2 dose vial
1 dose vial
Hepatitis B
2 dose vial
6 dose vial
10 dose vial
1 dose vial
CONTACT:
LG Gwanghwamun Bldg. 92, Sinmunno, 2-ga, Jongno-gu, Seoul 110-062, South Korea
Tel: 0082 2 6924 3147 | Fax: 0082 2 6924 3059
Tel: +82 2 3773 1114 | Fax: +82 2 3773 7012 | Website: www.lgls.co.kr/eng
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10
GREEN CROSS CORPORATION
KOREA
PROFILE:
GreenCross Cell is a cell therapy
company developed the anti-cancer
immunocell medicine ‘Immune Cell
LC’ and obtained approval as a liver
cancer drug in 2007.
The company initiated a phase III clinical
\trial Immuncell-LC with liver cancer
patients in 2008 and completed it in
2012. It has continued to conduct
research related to production of anticancer immunocyte drugs and research
on stem cell drugs.
WHO
PRE-QUALIFIED
VACCINE
WHO
PRE-QUALIFIED
VACCINE DOSAGE
Influenza (Seasonal)
10 dose vial
1 dose vial
Influenza A (H1N1) Pandemic
1 dose vial
In addition, it carries out projects on
consignment by utilizing its cell therapy
production facilities.
CONTACT:
107, Ihyeon-ro 30beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, Korea GREEN CROSS CORP.
Tel. +82.31.260.9300 | Fax: +82.31.260.9413
E-mail: Business/Export [email protected], Procurement & Importation [email protected]
Development [email protected], General Corporation Management [email protected]
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11
JAPAN BCG LABORATORY
JAPAN
PROFILE:
Japan BCG Laboratory was established in
1952 and has produced high-quality BCG
(Bacillus-Calmette Guérin) vaccine ever since.
Japan BCG Laboratory is the sole supplier of
this vaccine in Japan.
WHO
PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
BCG
20 dose ampoules
Working with UNICEF, WHO and the Pan
American Health Organization (PAHO),
Japan BCG Laboratory has distributed its BCG
vaccine in more than 50 countries worldwide,
and has become a respected & longstanding
supplier of high-quality products.
Japan BCG Laboratory has supplied more
than 2 billion doses of BCG vaccine over the
past 40 years.
CONTACT:
Head Office(International Department)
1-5-21 Otsuka, Bunkyo-ku, Tokyo, 112-0012 Japan
Tel: +81 03-5395-5583 | Fax: +81 03-5395-5580
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12
GPO-MPB GOVERNMENT PHARMACEUTICAL
ORGANIZATION MERIEUX BIOLOGICAL
THAILAND
PRODUCTS COMPANY LIMITED
MISSION:
To be a leader in pharmaceutical products and medical supplies beneficial and essential
to the Thai society with fairness.
To manufacture, sell, and supply quality pharmaceutical products and medical supplies
with an aim to achieve world-class standard.
To develop business to ensure competitiveness and self-sustainability.
To maintain price level of pharmaceutical products and medical supplies necessary for
the Thai society to ensure people’s accessibility.
To research and develop new pharmaceutical products and medical supplies to respond
to the need and necessity of the Thai society.
WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
4 dose vial
Measles
10 dose vial
CONTACT:
The Government Pharmaceutical Organization
75/1 Rama VI Road, Ratchathewi, Bangkok 10400 Thailand
Tel. 02-203-8000 | Fax. 02-354-8780 | Call Center : 1648
Website: www.gpo.or.th/Default.aspx?tabid=194&language=en-US
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13
PT BIO FARMA
INDONESIA
PROFILE:
Bio Farma is a State Owned Enterprise and 100% owned by the Government of Indonesia.
Bio Farma is the only producer of international quality vaccines and anti sera for human beings in
Indonesia, and being the largest one in Southeast Asia which is dedicated to produce international
quality vaccines and anti sera. This production of vaccines and anti sera are aimed to support the
national immunization program in actualizing for a better health quality of Indonesian people.
WHO PRE-QUALIFIED
VACCINE
WHO PRE-QUALIFIED
VACCINE DOSAGE
Diphtheria-Tetanus
10 dose vial
10 dose vial
Diphtheria-Tetanus- Pertussis
(whole cell)
10 dose vial
(whole cell) - Hepatitis B
10 dose vial
(whole cell) - Hepatitis B
10 dose vial
5 dose vial
Hepatitis B
1 dose uniject
Measles
10 dose vial
20 dose vial
Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3
20 dose vial
Polio Vaccine - Oral (OPV)
Monovalent Type 1
20 dose vial
Polio Vaccine - Oral (OPV)
Trivalent
20 dose tube
10 dose vial
Tetanus Toxoid
20 dose vial
1 dose uniject
10 dose vial
CONTACT:
MISSION:
Provide and develop life science product of
international standards to improve the quality of life.
VALUE:
Professional
Integrity
Team Work
Innovation
Customer Oriented
GOALS:
We aim to create sustainable value for
all Company stakeholders, to become Life
Science Company with global competitiveness. To achieve such objectives, we need
to accelerate the pace of change so that Bio
Farma’s vision towards being a world class
company can be achieved through the
integration of strategies to be implemented
in 2014.
PT Bio Farma (Persero)
Jl. Pasteur No. 28 Bandung – 40161 Indonesia
Tel: +62 22 2033755 | Fax : +62 22 2041306 | Email: [email protected] | Website: www.biofarma.co.id
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14
CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS
CO. LTD
CHINA
PROFILE:
Since the implementation of National
Immunization Program (NIP) in 1978,
vaccines produced by CNBG have
prevented over 300 million cases of
measles, diphtheria, pertussis, polio,
tuberculosis and tetanus.
Our products prevented more than
4 million deaths, and saved over 40
billion RMB in-patient costs. CNBG
served National Immunization Program (NIP) for 30 years. Over 80%
of vaccines for NIP in the country are
supplied by us.
Every Chinese person has been
vaccinated with our products. In 2010,
all 130 million doses measles
vaccines used for the nationwide
Measles Supplementary Immunization Campaign were supplied by us.
WHO
PRE-QUALIFIED
VACCINE
WHO
PRE-QUALIFIED
VACCINE DOSAGE
1 dose vial
5 dose vial
By the end of 2010, we have supplied over 141
million human portion of SA-14-14-2 Japanese
Encephalitis Vaccine to Southeast Asia, which
contribute to the control and prevention of
Japanese Encephalitis in Southeast Asia.
At the end of 2010, CNBG established a grant for
students & teachers of Chengguan No.1 Elementary School in Zhouqu, Gansu Province which has
been devastated by debris flows in August 2010.
This scholarship comes from donation of CNBG’s
staff and will last for 10 years.
In next 3 years, CNBG will fund RMB10 million to
help train CDC personnel in poor areas.
CONTACT:
No. 379, 3rd Section, Jinhua Road, Jiangjiang District, Chengdu, 610023 China
Tel: 86 28 8441 9831 (Lei Zhang) | Fax: 86 28 8441 9060
Website: www.en.cnbg.com.cn/html/news/2012/0201/756.html
Lei Zhang for Chengdu Institute of Biological Products
Tel: +86.28.8441.8887 | Email: [email protected]
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15
4 - 5 March 2015 | Pune, India
Vaccine World Summit is the most sought after vaccine industrial
gathering for emerging market manufacturers.
Led by overwhelming demand from the industry, we are bringing the 5th annual event in India and Vaccine Outstanding
Achievement Awards back to Pune in 2015.
Distinguished Panel of Speakers
Dr. Krishna Ella,
Founder &
Chairman,
Managing
Director, Bharat
Biotech, India
Dr. Suresh
Jadhav,
Executive Director,
Serum Institute of
India, India
Dr. Harish Iyer,
CEO,
Shantha
Biotechnics,
India
Dr. Reinhard
Glueck,
CSO,
Zydus Cadila,
India
Dr. Raj Mehta,
President,
CPL Biologicals,
Cadila
Pharmaceuticals,
India
Dr. Sunil Gupta,
Director,
CRI, CDSCO,
Kasauli, India
Dr. Sanjay
Gandhi,
General Manager,
Clinical R&D,
Medical Affairs,
GSK Vaccines,
India
Dr. Arani
Chatterjee,
Senior Vice
President,
Clinical Research,
Biological E,
India
Dr. Pradeep
Nagalkar,
Head of Quality
Control,
Haffkine-Bio
pharmaceuticals,
India
Dr. Upendra Jani,
Vice President,
QA,
Hester
Biosciences,
India
Dr. Karl
Birthistle,
Vice President,
Global Regulatory
Affairs, Abivax,
France
Mr. Anil Sood,
Vice President,
Manufacturing and
Site Head,
Panacea Biotec,
India
Gold Sponsor:
Lunch Sponsors:
Exhibitors:

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