With all of its U.S.-targeted manufacturing facilities, including a new sterile injectables plant, under FDA oversight, it's difficult for Indian generics maker Wockhardt to get a new product approved for the U.S. market. But it has managed to do just that by using contractors.
In a public filing last week, Wockhardt said that the FDA had approved its abbreviated new drug application for piperacillin and tazobactam for injection, a copy of Pfizer’s penicillin antibiotic sterile injectable Zosyn.
The drugmaker said in the filing that its Wockhardt Bio unit filed the ANDA in collaboration with Germany’s Fresenius Kabi and it is being manufactured in a Fresenius Kabi plant in Milan, Italy. But a Fresenius Kabi spokesperson told in-Pharma Technologist that Wockhardt Bio developed the drug and that Fresenius produced the API but that commercial production was being handled by a Recipharm operation in Italy.
Wockhardt has been trying to get a new sterile injectables plant in Shendra, Aurangabad, approved to sell products in the U.S., but the FDA issued that plant an untitled letter in January for many of the same shortcomings found at its other plants.
Earlier this month, the FDA issued India’s Wockhardt its seventh warning letter, this one for its plant in the U.S. In it the FDA lambasted the company for repeated and persistent manufacturing failings across its manufacturing network. It said that top execs have failed to deliver on promises of corporate-wide “corrective actions” in its manufacturing
“These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs,” the FDA said.