ANI
08 Dec 2022, 14:25 GMT+10
New Delhi [India], December 8 (ANI): The United States Food and Drug Administration on Thursday listed the Halol facility in Gujarat of Sun Pharmaceuticals under Import Alert.
According to a statement from the pharmaceutical company to the stock exchanges, the Import Alert implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with CGMP standards.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
The USFDA has excluded 14 products of the company from this Import Alert, subject to certain conditions.
According to the statement, for the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 per cent of the company's consolidated revenues, including the 14 excluded products as mentioned above.
The company said it continues to cooperate with the USFDA and would undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action. It said it remains committed to being CGMP-compliant and in supplying high-quality products to its customers and patients globally. (ANI)Get a daily dose of Breaking Property News news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Breaking Property News.
More InformationWASHINGTON, D.C.: New single-family home sales in the U.S. rose sharply in April to their highest level in over three years as builders...
VEVEY, Switzerland: Nestle is realigning its focus on its core food and beverage operations after expanding into areas like health...
DEARBORN, Michigan: Ford Motor Company has filed a lawsuit against several California lawyers and law firms, accusing them of cheating...
BRUSSELS, Belgium: U.S. drugmakers are charging significantly more for new treatments, particularly those targeting rare diseases,...
MINNETONKA, Minnesota: UnitedHealth shares took a sharp hit this week, after a report by the UK's Guardian alleged the healthcare giant...
HUNG YEN, Vietnam: A new US$1.5 billion luxury golf and residential project backed by the Trump Organization officially broke ground...
ORLANDO, Florida: For years, Universal Orlando played second fiddle to Disney's sprawling empire in Central Florida. Now, with the...
DUBLIN, Ireland: The Bank of Ireland has announced an ambitious new target to support the construction of 30,000 homes across the country,...
Man suspected in 6-victim Colorado Springs shooting turns himself in
Colorado man charged with attempted bombing of U.S. embassy in Israel
Body found in burning car in Pueblo along I-25 frontage road