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USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns

by Reshma Anand on  September 16, 2015 at 4:02 PM Corporate News   - G J E 4
The US Food and Drug Administration(FDA) has banned import of drugs from India-based, Polydrug Laboratories Pvt Ltd over quality control concerns. This is the 10th drug manufacturing plant to face such action during the course of this year.
USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns
USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns
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The FDA's "import alert" comes two months after Canada banned the same site, citing data integrity issues. Early in June, Europe also barred imports from the same plant for critical deficiencies, that included not recording customer complaints staff deliberately.

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Polydrug manufactures drugs to treat hypertension, fungal diseases, and muscle relaxants. The company's website cites that Polydrug exports these drugs to over 70 countries across Europe, North America and Asia.

The FDA action comes less than two weeks after Svizera Labs, a major Indian supplier of tuberculosis drugs to developing countries, was criticized by the World Health Organization for inadequate manufacturing standards and poor testing procedures.

Many other drug manufacturers from India, have gone under the scanner, facing bans for issues ranging from sanitation to data manipulation.

The latest FDA action takes the total number of Indian drug manufacturing facilities that currently stand barred from exporting to the United States to 44 between 2011 and now, according to the FDA website.

Source: Medindia
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