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WHO Prequalified Vaccines in Asia

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2014

PREFACEAs 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.

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The ranking is in no particular order and listed alphabeticallyThe content of this e-Book only represents the opinions of IMAPACAll information is provided by our partners or retrieved fromInternetThe vaccine and dosage information provided below is profiledfrom the WHO-prequalified vaccines list [correct as of 21st November 2014]

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Shanta BiotechnicsSerum Institute of India Ltd Panacea BiotechBiological E LimitedHaffkine Pharmaceutical CorporationZydus CadilaBerna Biotech Korea CorporationLF Life SciencesGreen Cross CorporationJapan BCD LaboratoryGPO-MPB Government Pharmaceutical OrganizationPT Bio FarmaChengdu Institute of Biological Products Co. Ltd

The genesis of Shantha Biotechnics Ltdcan 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 developingefficacious 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 pro-gramme 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 hasacquired Hyderabad-based ShanthaBiotechnics, which has been valued at euro 550 million (over Rs 3,770 crore).

Shantha Biotechnic Limited (Shantha) was acquired by Sanofi in July, 2009.Sanofi-aventis, a leading global pharma-ceutical company, discovers, develops and distributes therapeutic solutions to improve the quality of life for the public at large.

SHANTA BIOTECHNICSPROFILE:

INDIA

WHO PRE-QUALIFIED VACCINE

WHO PRE-QUALIFIED VACCINE DOSAGE

Cholera

Diphtheria-Tetanus-Pertussis (whole Cell)- Hepatitis B-Haemophilus Influenzae Type B

Hepatitis BT

Tetanus Toxoid

1 dose Vial

10 dose Vial1 dose Vial

2 (paediatric) or 1 (adult) dose Vial10 dose Vial1 paediatric dose Vial6 dose Vial20 dose Vial


3rd & 4th Floor, H.No: 5-10-173, Fateh Maidan Road, Basheerbagh, Hyderabad – 500004Tel: +91-66301000 | Email: [email protected] | Website: www.shanthabiotech.com

CONTACT:

w www.imapac.com/business_conference/vwsi20153

WHO PRE-QUALIFIED VACCINE WHO PRE-QUALIFIED VACCINE DOSAGE

BCG

Diphtheria-Tetanus

Diphtheria-Tetanus (for adults)

Diphtheria-Tetanus-Pertussis(whole cell)

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B

Hepatitis BHaemophilus Influenza E Type B

Influenza A (H1N1) - Pandemic

Measles

Measles and Rubella

Measles, Mumps and Rubella

Meningococcal A Conjugate 5 mcg/dose

Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3

Polio Vaccine - Oral (OPV) Trivalent

Rubella

Rabies

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus Influenza E Type B

Diphtheria-Tetanus-Pertussis (whole cell)-HaemophilusInfluenza E Type B

10 dose vial

10 dose vial20 dose vial1 dose ampoule

1 dose ampoule 10 dose vial20 dose vial



1 adult dose ampoule or vial10 paediatric dose vial1 paediatric doseampoule or vial10 dose adult vial

1 dose vial

5 dose vial1 dose vial10 dose vial1 dose vial2 dose vial5 dose vial10 dose vial5 dose vial1 dose vial2 dose vial

10 dose vial2 dose vial5 dose vial1 dose vial10 dose vial

10 dose vial20 dose vial


1 dose vial2 dose vial5 dose vial10 dose vial

1 dose vial

1 dose vial + ampoule (liquid/lyophilised combination)2 dose vial + ampoule (liquid/lyophilised combination)2 dose vial10 dose vial10 dose vial + vial (liquid/lyophilised combination)1 dose vial

1 dose vial + ampoule

Tetanus Toxoid 1 dose ampoule10 dose vial20 dose vial

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-suffi-cient 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 thecompany still not only exists but has been proliferated to bring down the prices ofnewer vaccines such as Hepatitis-Bvaccine, 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 areprotected from birth onwards.

SERUM INSTITUTE OF INDIA LTD

PROFILE:

INDIA


212/2, Hadapsar,Off Soli Poonawalla Road, Pune-411028, IndiaTel: +91-20-26993900 Email: [email protected] Website: www.seruminstitute.com

CONTACT:

20 dose vial

Meningococcal A Conjugate 10 mcg/dose 10 dose vial

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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 steadilyexpanded their infrastructure to include state-of-the-art Research and Development centersand facilities complying with cGMP standards, linked together by strong InformationTechnology backbone.

PANACEA BIOTECHPROFILE:

INDIA



Diphtheria-Tetanus-Pertussis (whole cell) -Hepatitis B -HaemophilusInfluenza E Type B


B-1 Extn./ A-27, Mohan Co-op. Industrial Estate, Mathura Road, New Delhi -110044, INDIATel: +91-11-26945270, 26974500, 41678000 | Email: [email protected]: www.panacea-biotec.com

CONTACT:

BIOLOGICAL E LIMITEDINDIA

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

CONTACT:


Biological E Limited was established over50 years ago. It is the first private sectorbiological products company in India andthe first pharmaceuticals company in SouthIndia. BE is also the pioneer in preventive medicine.

Biological E Limited supplies most of theessential 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.

PROFILE:WHO PRE-QUALIFIED VACCINE WHO PRE-QUALIFIED VACCINE DOSAGE

Diphtheria-Tetanus (for adults) 1 dose vial10 dose vial

Diphtheria-Tetanus-Pertussis(whole cell)

10 doses 1 dose vial

Japanese Encephalitis 1 dose vial

Tetanus Toxoid 1 dose vialToxoid 10 dose vial20 dose vial

Diphtheria-Tetanus-Pertussis (whole cell) - Hepatitis B - Haemophilus Influenza E Type B

1 dose vial1 dose vial (Fully liquid)10 dose vial10 dose vial (Fully liquid)

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 produc-tion 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.

HAFFKINE PHARMACEUTICAL CORPORATION

PROFILE:

INDIA

Acharya Donde Marg, Parel, Mumbai, IndiaTel: +91- 22 24129320-24129322 | Email: [email protected]

CONTACT:



Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3

Polio Vaccine - Oral (OPV) Monovalent Type 1

Polio Vaccine - Oral (OPV) Trivalent

20 dose vial

20 dose vial

20 dose vial


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ZYDUS CADILA INDIA

Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, IndiaTel: +91- 02717 664600 | Website: www.zyduscadila.com

CONTACT:

Zydus Cadila is an innovative global pharmaceutical company that discovers, de-velops, manufactures and markets a broad range of healthcare products. Vac-cine 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 indig-enously 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.

PROFILE:

WHOPRE-QUALIFIED VACCINE


Rabies 1 dose vial


Crucell is a pharmaceutical company engaged in the field of biotechnology that has as its goal the development, production and distribution of prod-ucts for the prevention of infectious diseases worldwide, particularlyvaccines and antibodies.

Crucell is currently engaged in thestruggle to twelve major infectiousdiseases with its baggage ofcommercially available vaccinesin the pediatric, respiratory, andvaccines for international.

BERNA BIOTECH KOREA CORPORATION- A Crucell Company

PROFILE:

KOREA

Songdo-dong 23, Harmony-ro 303beon-gilYeonsu-gun Incheon, 406-840, South KoreaTel: 82 3 2290 8400Fax: 82 3 2290 8409Website: www.bernabiotech.co.kr

CONTACT:



Diphtheria-Tetanus-Pertussis (whole cell) - Hepatitis B -HaemophilusInfluenza E Type B

Hepatitis B

1 dose vial

1 dose vial

1 dose vial (thiomersal free)

10 dose vial

LG LIFE SCIENCESKOREA

LG Gwanghwamun Bldg. 92, Sinmunno, 2-ga, Jongno-gu, Seoul 110-062, South Korea Tel: 0082 2 6924 3147 | Fax: 0082 2 6924 3059Tel: +82 2 3773 1114 | Fax: +82 2 3773 7012 | Website: www.lgls.co.kr/eng

CONTACT:

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 re-sulted 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 (Folli-trope™), 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.

PROFILE:

WHO PRE-QUALIFIED VACCINE WHO PRE-QUALIFIED VACCINE DOSAGE

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus Influenza E Type B

Hepatitis B


2 dose vial6 dose vial10 dose vial1 dose vial



GreenCross Cell is a cell therapycompany developed the anti-cancerimmunocell medicine ‘Immune CellLC’ and obtained approval as a livercancer drug in 2007.

The company initiated a phase III clinical\trial Immuncell-LC with liver cancerpatients in 2008 and completed it in2012. It has continued to conductresearch related to production of anti-cancer immunocyte drugs and researchon stem cell drugs.

In addition, it carries out projects onconsignment by utilizing its cell therapyproduction facilities.

GREEN CROSS CORPORATION

PROFILE:

KOREA

107, Ihyeon-ro 30beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, Korea GREEN CROSS CORP. Tel. +82.31.260.9300 | Fax: +82.31.260.9413E-mail: Business/Export [email protected], Procurement & Importation [email protected] Development [email protected], General Corporation Management [email protected]

CONTACT:


WHOPRE-QUALIFIED VACCINE DOSAGE


1 dose vial

Influenza (Seasonal)

Influenza A (H1N1) - Pandemic

JAPAN BCG LABORATORYJAPAN

Head Office(International Department)1-5-21 Otsuka, Bunkyo-ku, Tokyo, 112-0012 JapanTel: +81 03-5395-5583 | Fax: +81 03-5395-5580

CONTACT:

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.

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.

PROFILE:




BCG 20 dose ampoules

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.

GPO-MPB GOVERNMENT PHARMACEUTICALORGANIZATION MERIEUX BIOLOGICAL PRODUCTS COMPANY LIMITED

MISSION:

The Government Pharmaceutical Organization75/1 Rama VI Road, Ratchathewi, Bangkok 10400 ThailandTel. 02-203-8000 | Fax. 02-354-8780 | Call Center : 1648Website: www.gpo.or.th/Default.aspx?tabid=194&language=en-US

CONTACT:



Japanese Encephalitis

Measles

4 dose vial

10 dose vial


THAILAND

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.

PT BIO FARMAINDONESIA

PT Bio Farma (Persero)Jl. Pasteur No. 28 Bandung – 40161 IndonesiaTel: +62 22 2033755 | Fax : +62 22 2041306 | Email: [email protected] | Website: www.biofarma.co.id

CONTACT:

PROFILE:

Provide and develop life science product of international standards to improve the qual-ity of life.

MISSION:WHO PRE-QUALIFIED VACCINE


Diphtheria-Tetanus 10 dose vial

Diphtheria-Tetanus (for adults) 10 dose vial

Diphtheria-Tetanus- Pertussis (whole cell)

10 dose vial

Diphtheria-Tetanus- Pertussis (whole cell) - Hepatitis B

10 dose vial

Diphtheria-Tetanus- Pertussis (whole cell) - Hepatitis B


Hepatitis B 1 dose uniject

Measles 10 dose vial20 dose vial

Polio Vaccine - Oral (OPV) Bi-valent Types 1 and 3

20 dose vial

Polio Vaccine - Oral (OPV) Monovalent Type 1

20 dose vial

Polio Vaccine - Oral (OPV)Trivalent

20 dose tube10 dose vial

Tetanus Toxoid 20 dose vial1 dose uniject10 dose vial


VALUE:ProfessionalIntegrityTeam Work

We aim to create sustainable value forall Company stakeholders, to become LifeScience Company with global competitive-ness. 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 theintegration of strategies to be implemented in 2014.

GOALS:

InnovationCustomer Oriented


WHOPRE-QUALIFIED VACCINE DOSAGE


Japanese Encephalitis

CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS CO. LTD

PROFILE:

CHINA

No. 379, 3rd Section, Jinhua Road, Jiangjiang District, Chengdu, 610023 ChinaTel: 86 28 8441 9831 (Lei Zhang) | Fax: 86 28 8441 9060Website: www.en.cnbg.com.cn/html/news/2012/0201/756.html

Lei Zhang for Chengdu Institute of Biological ProductsTel: +86.28.8441.8887 | Email: [email protected]

CONTACT:


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 Pro-gram (NIP) for 30 years. Over 80% of vaccines for NIP in the country are supplied by us.

Every Chinese person has beenvaccinated with our products. In 2010, all 130 million doses measles vaccines used for the nationwideMeasles Supplementary Immuniza-tion Campaign were supplied by us.

By the end of 2010, we have supplied over 141 million human portion of SA-14-14-2 JapaneseEncephalitis Vaccine to Southeast Asia, which contribute to the control and prevention ofJapanese Encephalitis in Southeast Asia.

At the end of 2010, CNBG established a grant for students & teachers of Chengguan No.1 Elemen-tary 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.

Dr. Krishna Ella, Founder &Chairman,ManagingDirector, Bharat Biotech, India

Dr. Raj Mehta, President,CPL Biologicals, CadilaPharmaceuticals, India

Dr. Pradeep Nagalkar, Head of Quality Control,Haffkine-Biopharmaceuticals, India

Dr. Upendra Jani, Vice President, QA,HesterBiosciences,India

Dr. KarlBirthistle, Vice President,Global Regulatory Affairs, Abivax,France

Mr. Anil Sood, Vice President,Manufacturing and Site Head,Panacea Biotec,India

Dr. Sunil Gupta, Director,CRI, CDSCO, Kasauli, India

Dr. SanjayGandhi, General Manager,Clinical R&D, Medical Affairs,GSK Vaccines,India

Dr. AraniChatterjee, Senior VicePresident,Clinical Research,Biological E,India

Dr. SureshJadhav, Executive Director,Serum Institute of India, India

Dr. Harish Iyer, CEO,ShanthaBiotechnics,India

Dr. Reinhard Glueck, CSO,Zydus Cadila,India

Led by overwhelming demand from the industry, we are bringing the 5th an-nual event in India and Vaccine OutstandingAchievement Awards back to Pune in 2015.

4 - 5 March 2015 | Pune, India

Distinguished Panel of Speakers

Vaccine World Summit is the most sought after vaccine industrial gathering for emerging market manufacturers.

Exhibitors:Lunch Sponsors:Gold Sponsor:

2014 - home - imapac - imagine your impact · 2014 preface as our 5th annual vaccine world summit...

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