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Questions have been raised about how Australia ensures the quality of its imported medicines after a major pharmaceutical ...
The US Food and Drug Administration (FDA) admonished Sun Pharmaceutical Industries in a recent warning ... These violations prompted FDA to place the firm on import alert on 7 December. FDA inspected ...
In a warning letter, the FDA has highlighted a series of lapses at Sun Pharma’s Gujarat plant, which has been put on an import alert list by the US drug regulator. In the letter dated December ...
Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India ...
A Boca Raton pharmaceutical company has agreed to settle charges with the Food and Drug Administration that allege improper ...
Sun Pharma plans to submit a new drug application for the alopecia candidate to the FDA in the first half of 2023.
Concert Pharmaceuticals and its alopecia drug have found a new home. Mumbai-based Sun Pharma announced early Thursday that it ...
"Sun Pharma’s immediate focus would be to follow Concert’s plan to submit a New Drug Application (NDA) to the USFDA in the ...
An import alert may follow a warning letter or OAI classification if the FDA is not satisfied with ... subject to the exemption of certain products. Sun Pharmaceutical Industries' Halol facility ...
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including its failure to follow appropriate written procedures designed to prevent microbiological contamination ...
Sun Pharmaceutical Industries has announced that one of its wholly-owned subsidiaries has launched a novel anti-cancer drug, Palbociclib, in India for patients who have advanced breast cancer ...
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