Wockhardt inaugurates a ‘state-of-the-art’ manufacturing facility for the production and packaging of sterile dry powder injection in Dubai
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, “With Wockhardt’s commitment to R&D, we have five 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 recognised as a 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 five 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 five 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.
“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 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 segmentto the world from UAE. The facility is spread over 10,000 sq. meters of space and the design takes into account the requirements for product & personnel safety and product quality with complete close transfers and high levels of sterility assurances.