Wockhardt sets up its first manufacturing and R&D unit in Middle East
Posted on July 31, 2018
“Wockhardt Group, a research based Global Pharmaceutical and Biotech major, sets up its first facility in Middle East for manufacturing of NCEs (New Chemical Entities) catering to the global markets through its Dubai arm of its subsidiary Wockhardt Bio AG.”
With an aim to grow and further establish their international presence in pharmaceutical manufacturing, Wockhardt inaugurated a ‘state-of-the-art’ manufacturing facility for the production and packaging of sterile dry powder injection in Dubai. On approval of the new drug by US FDA, this manufacturing facility will be commissioned for commercial production.
During the inauguration of the new facility, Dr. Habil Khorakiwala, Founder Chairman of Wockhardt said, “Wockhardt is poised for a quantum leap into the future. It is a future of dynamic changes, exciting possibilities and endless potential to further its goal of ‘Life Wins’ and Wockhardt is committed to shaping this future. With Wockhardt’s commitment to R&D, we have 5 breakthrough New Chemical Entities (NCEs) that have been accorded Qualified Infectious Disease Product (QIDP) status by US FDA. With the new facility in Middle East, we aim to focus on our commitment in developing NCEs to fight the health issues faced.”
Antimicrobial resistance (AMR) – the ability of infections to resist antibiotics to work against it is increasingly recognized as growing global health problem. Infections caused by antimicrobial resistant strains of bacteria-also called “superbugs” are unlikely to respond to standard treatments resulting in prolonged illness and a greater risk to health, and severely impacting clinical outcomes, leading to further higher healthcare costs due to consumption of healthcare resources.
Wockhardt currently has 5 novel antibiotic drugs in advanced stages of global clinical development which will be effective against these “superbugs” threats identified by the Center of Disease Control, USA.
Considering the strategic importance of these antibiotics, the US FDA has granted Qualified Infectious Disease Program (QIDP) status to the 5 novel antibiotic drugs.
“Wockhardt has dedicated significant resources for the discovery and development of novel antibiotics. These novel drugs in advanced stages of global development are a culmination of 20 years of dedicated and focused research in the antibiotics therapy segment with an aim to improve the quality of life”, said Dr. Murtaza Khorakiwala, Managing Director of Wockhardt. “The facility will work on the exhibit batches and will be offered for inspection by the regulators at an appropriate time”, he further added.
Dr. Mahesh Patel, Chief Scientific Officer of New Drug Discovery, Wockhardt further added, “Wockhardt’s drug discovery program has immensely benefitted from global collaborations with universities and scientists of international repute in the areas of public health, Infectious diseases and clinical microbiology”.
“Wockhardt conducted extensive studies for identifying a region in the Middle East to establish a strong manufacturing presence for its advanced patented drugs. JAFZA was found to be appropriate for the factory premises for manufacturing patented proprietary drugs for global markets”, added Dr. Habil Khorakiwala.
Wockhardt Bio AG manufacturing facility is designed to meet standards of various international regulatory agencies and the standards as set by the Local Ministry of Health. The facility meets the needs of Aseptic Dry Powder Injectable manufacturing and filling with a high quality operation. This facility is dedicated to launch its novel New Chemical Entities in the Antibiotics segment to the world from UAE.
The facility is spread over 10,000 sq. meters of space, self-sufficient for handling Warehousing, Manufacturing Operations, Product Testing and Product Stability. The facility is equipped with best-in-class and fully automated manufacturing equipments and clean utility systems. The design takes into account the requirements for Product & Personnel Safety and Product Quality with complete close transfers and high levels of sterility assurances.
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