The U.S. FDA made nine observations highlighting manufacturing violations following inspection of Wockhardt's new sterile injectable drugs facility in Shendra, Aurangabad.
Wockhardt CEO Habil Khorakiwala did not disclose the specifics on the violations, but told the media the observations are not critical in nature and will be resolved in the next 2-3 months.
The facility, touted by the Indian drugmaker as "the first of its kind in Asia" was designed to produce difficult-to-manufacture injectable products. The facility is currently supplying to markets in the UK and Ireland.
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