Banned Wockhardt Plant Gets Ok from UK Agency; FDA Ban Remains

Source: money source

Dec 03, 2015

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has given Wockhardt's Maharashtra-based Chikalthana facility a good manufacturing practice certificate after inspection, lifting the import restrictions completely.

In October of 2013, the MHRA revoked Wockhardt's GMP certificate from its Chikalthana plant, meaning Wockhardt was no longer able to supply products to Britain. The only exception to this ban were critical APIs.

The U.S. FDA also banned exports from the generic drug maker's Waluj and Chikalthana plants in Maharashtra in 2013, citing production quality lapses; the bans remain.

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