Wockhardt opens antibiotics facility in Dubai 2nd August 2018
Wockhardt, a Mumbai, India-headquartered pharmaceutical company, has inaugurated a new manufacturing facility in Dubai for producing new antibiotics. The facility is designed for producing and packaging sterile dry-powder drugs for injection. The facility consists of 10,000 square meters of space for handling, warehousing, manufacturing operations, product testing and product stability.
With the US Food and Drug Administration’s (FDA) approval of one of the company’s new drugs, Wockhardt says the manufacturing facility will be commissioned for commercial production.
Wockhardt has five antibiotic drugs in advanced stages of global clinical development, which are designed to be effective against antimicrobial resistant strains of bacteria. The FDA has granted these drugs as Qualified Infectious Disease Products (QIDP). Under the QIDP program, new drug applications that are designated as QIDP can receive fast-track designation, priority-review designation, and a possible five-year extension of any exclusivity that the application qualifies for upon approval, according to information from the FDA.
“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 [the] US FDA,” said Habil Khorakiwala, Chairman of Wockhardt, in a July 29, 2018 company statement.