USFDA bans import from Polydrug Labortaries
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Mumbai based Polydrug Laboratories Ambernath manufacturing plant is now facing a ban from USFDA; exactly two months after Canada banned the same site, citing data integrity issues. Europe also barred imports from the plant in early June citing critical deficiencies, including that staff deliberately did not record customer complaints.
Polydrug makes drugs to treat hypertension, fungal diseases, and muscle relaxants, and exports them to more than 70 countries across Europe, North America and Asia, according to its website.
The US Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action.
The company did not immediately respond to a request seeking comment on Monday, after the FDA posted a notice of the ban on its website.
The FDA action comes less than two weeks after Svizera Labs, a major Indian supplier of tuberculosis drugs to developing countries, was criticised by the World Health Organization for inadequate manufacturing standards and poor testing procedures.
Polydrug makes drugs to treat hypertension, fungal diseases, and muscle relaxants, and exports them to more than 70 countries across Europe, North America and Asia, according to its website.
The US Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action.
The company did not immediately respond to a request seeking comment on Monday, after the FDA posted a notice of the ban on its website.
The FDA action comes less than two weeks after Svizera Labs, a major Indian supplier of tuberculosis drugs to developing countries, was criticised by the World Health Organization for inadequate manufacturing standards and poor testing procedures.
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