The US Food and Drug Administration has given approval to a facility of Eskayef Pharmaceuticals Limited,
an achievement that would allow the company to enter the world's largest drug market.
"Unwavering commitment to quality has always been at the forefront of Eskayef's drive to serving humanity, and receiving this accreditation from the US FDA has solidified our hold as the epitome of quality products for the people of Bangladesh and the world," said Simeen Rahman, group CEO of Transcom Limited and managing director and CEO of Eskayef Pharmaceuticals Ltd.
The US FDA issues export certificates for approved or licenced drugs and for unapproved drugs that meet certain legal requirements.
The approval of FDA is important, because it validates the need for research on how drugs work on patients. In order to receive FDA approval for a drug or a medical device, the manufacturer must prove to the FDA that the item is "safe and effective".
Based upon the rigorous inspection at Eskayef’s Tongi plant by the Medicines and Healthcare products Regulatory Agency (MHRA) of Department of Health of UK Government, the Tongi plant of Eskayef Pharmaceuticals Ltd. has been formally approved by UK MHRA on August 2008. In 2011, Eskayef got re-accreditation from UK MHRA for consistantly maintaining the quality, efficacy and safety of its products.
1st Accreditation : 2008
Re Accreditation: 2011, 2014 & 2017
Eskayef is the only company in Bangladesh that has achieved accreditation from UK MHRA (Medicines and Healthcare products Regulatory Agency), TGA Australia and Veterinary Medicines Directorate (VMD) of United Kingdom.
European Union GMP
Eskayef Pharmaceuticals is the first ever Bangladeshi company to get the approval of EU GMP, a highly prestigious standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards. All the 27 member states of European Union (EU) acknowledge the EU GMP certificate. A very few Asian pharmaceutical companies could avail the approval so far.
The world class pharmaceutical manufacturing facility of Eskayef Pharmaceuticals Ltd. at Tongi has achieved approval from Therapeutic Goods Administration (TGA), Australia in June 2010.
1st Accreditation: 2010
Re Accreditation: 2012, 2015
Therapeutic Goods Administration (TGA) is a division of the Australian Department of Health and Ageing, which is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods are of an acceptable standard. This TGA approval further reinforces high standards of quality, safety and efficacy of Eskayef products, opens Australian and other highly regulated markets for Eskayef and also depicts its Total Quality Management approach.
Following the accreditation for human medicines by the Medicines and Healthcare products Regulatory Agency (MHRA) of Department of Health of UK Government, the Tongi plant of Eskayef Pharmaceuticals Ltd. has also been formally approved by the Veterinary Medicines Directorate (VMD) of United Kingdom for its veterinary medicine manufacturing unit.
The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United Kingdom.
The Brazilian Health Regulatory Agency (Anvisa) is an organization linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS).
Anvisa’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies.
The GMP Certificate in Dubai is proof of compliance with the Good Manufacturing Practice Standards followed by the Pharmaceutical Manufacturer.
Organizations in the field of pharmaceuticals, healthcare sectors, including their buildings, environment, methods of documentation, work procedures, after-sale services, etc. is assessed to ensure quality control and adherence to safety regulations through this certification.