Incepta Vaccine Ltd has launched its vaccine bulk manufacturing facility in Savar, outside the capital. Honorable health Minister Mohammed Nasim, MP inaugurated the facility on Dewan Idris Road in Zirabo on Thrusday, 28 July.
An internationally bulk manufacturing facility has been developed providing the best environmental conditions for performing the operations. The facility can manufacture both Bacterial and Viral bulk antigen. These make us less dependent on import and help to become a self-sufficient vaccine manufacturing country.
Addressing the inaugural ceremony, the minister said now Bangladesh is able to export medicines to 90 countries because of their high quality. Bangladesh is now capable of manufacturing life saving vaccine and successfully reduces the dependency on imported vaccines. ‘We will take the initiatives to get the WHO authorization which is needed for export of vaccines.’ Nasim said.
Director General of Drug Administration, Major General Md Mustafizur Rahman, Secretary General of Bangladesh Association of Pharmaceutical Industries, SM Shafiuzzaman were also present there as special guest.
- Public-private collaboration among Incepta Vaccine Ltd, IVI, and icddr,b
- Following technology transfer from IVI to Incepta Vaccine Ltd, clinical trials to start in Dhaka, Bangladesh
The International Vaccine Institute (IVI), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), and Incepta Vaccine Ltd. announced today initiation of a clinical trial for Cholvax®, an inactivated oral cholera vaccine, in Dhaka, Bangladesh.The three groups are collaborating on its clinical development in order to register the vaccine in Bangladesh, the first oral cholera vaccine to be registered in the country.
The clinical trial will assess vaccine safety and immunogenicity in 2,052 people 1-45 years of age in Dhaka. As the trial sponsor, IVI will lead this research effort in collaboration with icddr,b, an international health research organization based in Bangladesh, and will also monitor the trial for quality assurance and provide technical support in data management and evaluation of the participants safety as well as immune response to the vaccine. Incepta, the first human vaccine manufacturer in Bangladesh, will be responsible for manufacturing and quality control of clinical lots of Cholvax® for the trial. The trial is supported by the Bill & Melinda Gates Foundation.
The partnership between IVI and Incepta began in July 2014 when IVI transferred the technology for oral cholera vaccine production and quality control methods to the company. Both IVI and Incepta are committed to developing the vaccine for the public sector in Bangladesh where a high burden of cholera exists. This is the first collaboration between IVI and Incepta. The two organizations are also working together on the development of a typhoid conjugate vaccine.
The vaccine is a bivalent killed whole-cell oral cholera vaccine given orally in two doses over a 14-day interval and intended for use in people one year old and above. It was originally reformulated by IVI and developed through an international public-private partnership led by IVI, with partners from Sweden, India, Vietnam, and South Korea, and with support from the governments of South Korea and Sweden, and the Bill & Melinda Gates Foundation.
“The collaboration with Incepta and icddr,b will result in a vaccine that can reduce needless suffering of so many people from a debilitating and potentially fatal disease,” said Dr. Jerome Kim, IVI’s Director General, “This collaboration is critical to achieving our goal of making vaccines available and accessible for the world’s most vulnerable and impoverished people.”
Incepta Vaccine Ltd. observed World Hepatitis Day 2015 on July 28th in Bangladesh. The day was observed with full of events in relation to create awareness to prevent viral hepatitis.
“Prevent Hepatitis, It’s up to you” with this slogan, a Cycle Rally has been initiated from the Central Shahid Minar and circled major roads of Dhaka city. Mr.Mahbubey Alam, Attorney General, Government of the People’s Republic of Bangladesh, Mr. Sayeed Khokon, Honorable Mayor, Dhaka City (South) and Prof. Mohammad Ali, Secretary General, National Liver Foundation of Bangladesh inaugurated the rally and wished to provide all out support for awareness activities for viral hepatitis.
Special program was broadcasted in television & different topics were transmitted in popular FM Radio whole day. The importance of prevention of viral hepatitis was also published in social media and in the newspaper. Posters, banners, leaflets were widely circulated on this auspicious day.
Vaccination for influenza and meningitis are two mandatory prerequisite for all Bangladeshi hajj pilgrims. Government of Bangladesh ensured vaccination of these two vaccines one month prior to the departure for Saudi Arabia.
In this year 2015, Incepta Vaccine Ltd is very much delighted to provide supply of influenza and meningitis vaccine to Government of Bangladesh for the hajj pilgrimages. Incepta Vaccine Ltd manufactured Influenza vaccine by the name of “Influvax” and Meningococcal polysaccharide vaccine by the name of “Ingovax” for meningitis. It has been a pride for the Incepta to be a part of this novel activity. Incepta pray for the safety and wellbeing of all Bangladeshi hajj pilgrims.
Antivenom injection is the preparation of snake venom antiserum. In Bangladesh, about 8000 snake bites occur annually with more than 20% mortality. Snake bite causes serious systemic or neurological complications such as bleeding disorder leading to fatal hemorrhage, permanent disability or death. Treatment of snake bite is neglected and is left to traditional ozha or kaviraj which lead to death. Snake venom antiserum is the mainstay of treatment after snake bite. But in Bangladesh, this life saving antiserum was not available everywhere in every season due to there is no local manufacturer, lack of cold chain system. Now Incepta Vaccine Ltd has introduced snake venom antiserum for the first time in Bangladesh with the brand name of Antivenom. Antivenom is manufactured by applying high tech lyophilization technique so that it can be stored at room temperature and highly stable. Antivenom is available in 10 ml in vial after reconstitution that should be given as infusion.
Influenza vaccine protects against influenza viruses during influenza season. Flu virus causes respiratory infection which passes through the air and enters the body through nose or mouth. It spreads around the world in a yearly outbreak resulting in about 3 to 5 million cases. Flu leads to severe complication for chronically ill patient like Asthma, COPD, Diabetes, Heart disease. Flu can easily be prevented by vaccination before starting of every flu season. In Bangladesh, this life saving vaccine was imported, which was not available everywhere in every season. Now Incepta Vaccine Ltd has introduced Influenza vaccine for the first time in Bangladesh with the brand name of Influvax. Influvax vaccine is manufactured with the WHO recommended flu viruses (A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 ) for northern hemisphere that are recommended for our country. Influvax is available in 0.5 ml vial that can be given intramuscularly.
Anti rabies vaccine is recommended as soon as possible after exposure to rabid animal to prevent rabies. However, in severe cases like WHO category-III bite only anti rabies vaccine is not enough to save life. In this case rabies immunoglobulin is recommended by WHO to ensure immediate protection. In Bangladesh, this life saving rabies immunoglobulin was imported, which was expensive and not available everywhere. Now Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd has introduced Rabies Immunoglobulin first time in Bangladesh with the brand name of Rabix-IG. Rabix-IG is available in 5 ml vial that can be given intramuscularly.
Tetanus antitoxin provides immediate protection against tetanus in tetanus prone wounds that can be happened in our life any time. About 73% cases of tetanus infection are caused by acute injuries or wounds. Bangladesh was fully dependent on imported tetanus antitoxin to prevent this deadly disease. Now Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd has introduced Tetanus antitoxin first time in Bangladesh with the brand name of Vaxitet-IG. Vaxitet-IG is available in 1 ml vial that can be given intramuscularly or subcutaneously.
Hepatitis B virus infection is one of the major burdens for Bangladeshi people. More than 10 million people are suffering from hepatitis B virus infection. Moreover, Bangladesh was fully dependent on imported vaccine to prevent this deadly infectious disease. Now Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd has introduced Hepatitis B vaccine first time in Bangladesh with the brand name of Hepa-B. Hepa-B is available in vial of 0.5 ml for pediatric and 1 ml for adult that can be given intramuscularly.
The first ever Human Vaccine manufacturing plant of Incepta Vaccine Ltd was officially inaugurated by the Honorable Health & Family Welfare Minister Prof. Dr. A. F. M. Ruhal Haque MP. Honorable Senior Secretary of Health & Family Welfare Ministry Md. Humayun Kabir, National Professor M. R. Khan, Director General of Drug Administration Major General Md. Abul Kalam Azad, Additional Director General of Directorate General of Health Services Prof. Dr. A.F.M. Saiful Islam and Director of Primary Health Care and Line Director of MNC & AH Dr. Syed Abu Jafar Md. Musa were present in the inauguration program as special guests. Abdul Muktadir, Managing Director of Incepta Vaccine Ltd, Mrs. Hasneen Muktadir, Director, Planning & Commercial, Director Jahiruddin Mahmud, Abdul Mukit Majumdar, Abdur Rashid Majumdar, Mahbubul Karim, Director, Technical Operations and other senior officials of Incepta were also present in the program.
In his speech, honorable Minister of Health & Family Welfare Prof. Dr. A. F. M. Ruhal Haque said “I am appreciating such initiative of Incepta Vaccine Ltd. At present our Government needs to spend several hundred crore Taka to import the necessary vaccines for EPI program. But, now we can save huge amount of foreign currency for such initiative of Incepta Vaccine Ltd.” Honorable Minister also visited the newly constructed 3 stored vaccine facilities which consist of 75000 square-feet, animal house which is required to ensure the efficacy of manufactured vaccines and also cold chain system which is important to maintain the efficacy of vaccine. He appreciated much to see such a world class vaccine plant and its facilities.
National Professor M. R. Khan said “Incepta has been supplying medicine of supreme quality from its inception. Their initiative makes a remarkable appreciation to reduce the dependency on foreign medicine.”
Abdul Muktadir, Managing Director of Incepta Vaccine Ltd said “in the near past we had to import essential vaccines from foreign countries. But now we are manufacturing vaccines in our own country. We have constructed a totally new and enormous vaccine plant according to the guidelines of WHO GMP.” He also said “the annual production capacity of our vaccine plant is about 18 crore vials which will not only fulfill the annual demand of EPI program but also provide us the opportunity to export these vaccines in the foreign countries.”
In conclusion, Mr. Muktadir promised to make all these high-tech and life saving vaccines available and affordable for the people of our country and sought overall assistance from the Government of Bangladesh for such endeavor.
Incepta Vaccine Ltd is the first Human vaccine company in Bangladesh, developed with primary objective to provide preventive medicine to vast majority of population at an affordable price. It is a new state of the art facility to manufacture vaccine in Bangladesh for the first time. The facility is fully compliant with WHO GMP guidelines. It has the following unique features:
Four German filling lines, independent of each other so that four different products can be manufactured simultaneously. Each area has dedicated HVAC system to prevent cross contamination. All the filling area rooms are equipped with terminal HEPA filters, with required air changes so as to create Class A, B, C & D environment, as the requirement of GMP. Each filling line has a sterilizing autoclave and decontamination autoclave. Each line is connected to independent visual inspection and labeling machine so as to prevent the chances of cross contamination
It has an advanced fully GMP compliant R&D facility which can independently handle several projects simultaneously involving bacteria and virus.
It has well equipped microbiology and chemical laboratory.
It also has a large lab animal house covering around 24,000 square feet area which has bio safety level 2 standard lab for testing of various vaccines which involve challenge with infectious organisms.
It has unique cold chain system to maintain the required temperature in every step of filling to packaging. It has well designed spacious cold rooms to store raw materials and finished products. It has 4 cold rooms of temperature within 2-8 °C and 2 cold rooms of temperature -20 °C to store raw materials and finished products.
Incepta Vaccine Ltd can produce any dose size from 0.1ml to 15 ml, with 4 different products simultaneously and has capacity to fill more than 2,40,000 ampoules and 3,60,000 vials per day. The yearly capacity is 180 million vials and ampoules. To conduct the immunization program of EPI, yearly demand of vaccine is 21 million vials and other than EPI yearly demand is 10 million vials which is increasing day by day. The production capacity of this facility is enough to meet the local demand and export.
Incepta Vaccine Ltd is now manufacturing and marketing Typhoid vaccine (Vaxphoid), Rabies vaccine (Rabix-vc) and Tetanus vaccine (Vexitet). In near future Hepatitis B, Polio, Measles, Rubella, Tetanus antitoxin, Rabies immunoglobulin, Pentavalent and all other necessary vaccines will be manufactured. Incepta Vaccine Ltd is committed to provide all high tech life saving vaccines to the people at affordable price.
Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd has introduced tetanus vaccine in Bangladesh market with the brand name of Vaxitet. Tetanus vaccine (Vaxitet) will help to save millions of neonates and mother from life threatening tetanus. Vaxitet will be available to patients at affordable price in 0.5 ml ampoule and can be given intramuscularly.
Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd has introduced life saving rabies vaccine in Bangladesh market with brand name Rabix-vc. In Bangladesh, more than 2000 people die from rabies every year which is highest in the world. But acute shortage, counterfeit, inadequate availability of imported vaccine, doubt with potency of vaccine due to improper maintenance of cold chain during transportation and high cost are major drawback to prevent this deadly disease. Now Incepta has stepped forward to manufacture high quality and affordable rabies vaccine in Bangladesh market. Rabix-vc is marketed in 1 ml vial which can be given intramuscularly.
Every year Bangladesh Government has to purchase more than 90 million doses of different vaccines to initiate the Expanded Program on Immunization (EPI) for children of 0-1 year. In private sector other than EPI, every year more than 30 million doses are required. This quantity is increasing day by day. Huge foreign currency is spent to purchase these vaccines. Since its inception, Incepta is always trying to fill up the therapeutic gap by providing the newer and modern needful medicines. Incepta Vaccine Ltd, a sister concern of Incepta Pharmaceuticals Ltd introduced first vaccine Vaxphoid, a vaccine to prevent typhoid fever which is one of the major causes of childhood death in Bangladesh.
Incepta Vaccine Ltd is the first Human vaccine company in Bangladesh, developed with primary objective to provide preventive medicine to vast majority of population at an affordable price. It is a new state of the art facility to manufacture vaccine in Bangladesh for the first time. The facility is fully compliant with WHO GMP guidelines. It has an advanced fully GMP compliant R&D facility which can independently handle several projects simultaneously involving bacteria and virus. Incepta has well equipped microbiology and chemical laboratory, a large lab animal house covering around 24,000 square feet area which has bio safety level 2 standard for testing of various vaccines.
Incepta has unique cold chain system to maintain the required temperature in every step of filling to packaging. It has well designed spacious several cold rooms to store raw materials and finished products. It has 4 cold rooms of temperature within 2-8 °C and 2 cold rooms of temperature -20 °C to store raw materials and finished products.
In near future, Rabies, Tetanus, Hepatitis B, Polio, Measles, Rubella, Tetanus antitoxin, Rabies immunoglobulin, Pentavalent and all other necessary vaccines will be manufactured. Incepta Vaccine Ltd is committed to provide all high tech life saving vaccines to the people of Bangladesh at affordable price.
Incepta Vaccine Limited, a sister concern of Incepta Pharmaceuticals Ltd received GMP certificate from the Directorate General of Drug Administration, Ministry of Health & Family welfare, Government of the Peoples Republic of Bangladesh.