India’s Wockhardt saw its losses widen last year as its burgeoning regulatory issues with the FDA continue to chainsaw away at its finances.
Last week, the Mumbai-based drugmaker reported (PDF) a fourth-quarter loss of 1.74 billion rupees ($27 million) compared to a loss of 53.8 million rupees ($869,000) in the same quarter a year ago. That was on revenues of 9.20 billion rupees ($143 million) for the quarter.
In the U.S., sales fell to about $112.8 million for the fiscal year, down from $149.8 million in the previous fiscal year, which for Wockhardt ends March 31. It said that U.S. sales last year accounted for 18% of its total, down from 22% last year and way off from the roughly 50% that it made up before its regulatory issues began to mount, and so has the agency’s frustration with the Indian drugmaker.
The extent of those problems started to become obvious in 2013, when the agency banned products from its plants in Waluj and Chikalthana for a variety of problems that it laid out later in warning letters.
That led the regulatory agency to start taking a closer look at the Indian drugmaker’s manufacturing operations around the globe. And with each look, the agency has uncovered problems, frequently repeats of issues pointed out in previous inspections.
The FDA laid bare its frustrations in a warning letter in March when it lambasted the company for repeated and persistent manufacturing failings across its manufacturing network and ordered it to do a top-to-bottom rework of its production procedures at all of its FDA-approved facilities.
That warning letter, its seventh, said that in multiple meetings, Wockhardt officials “have repeatedly discussed and promised corporate-wide corrective actions.” Yet, the FDA said, when its investigators return to or inspect another Wockhardt plant, they find the company persistently making the same mistakes.
These observations came in a warning letter for Wockhardt’s Morton Grove Pharmaceuticals site in Illinois, but the company has also received warning letters for plants in India, including one for an API plant in Ankleshwar, Gujarat, whose problems led to a complete response letter for a new-generation antibiotic that was under review for Chapel Hill, North Carolina-based Cempra.
It has also received a warning letter for a sterile injectables plant in the U.K. and an untitled letter for a brand-new sterile injectables plant in India that has yet to get FDA approval because of its shortcomings.