Search For "food and drug administration"
Marlboro maker ditches Juul and buys NJOY
Updated : 1 week, 6 days ago IST
The deal for NJOY, one of the few e-cigarette makers whose products have clearance from federal regulators, includes an additional USD 500 million if the Food and Drug Administration authorises additional NJOY products.
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Maharashtra FDA issues show cause notices to 17 firms making cough expecto
Updated : 2 weeks, 3 days ago IST
Maharashtra's Food and Drug Administration on Friday said it issued show cause notices to 17 companies manufacturing cough expectorants, instructed four companies to stop their production and terminated licences of six companies.
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Drug regulatory body initiates probe after US FDA flags contamination risk
Updated : 1 month, 2 weeks ago IST
After the US regulator Food and Drug Administration warned consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination", the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have ini
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US regulator conducts inspection of Piramal's unit in US
Updated : 2 months ago IST
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the
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Lupin gets US regulator's nod for Prasugrel tablets used in heart ailments
Updated : 2 months, 1 week ago IST
The product will be manufactured at Lupin's facility in Goa, according to a statement from the pharma firm.
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Aurobindo Pharma arm receives regulator's nod to make, market Azacitidine
Updated : 2 months, 2 weeks ago IST
The product is expected to be launched this month, according to the statement from Aurobindo Pharma
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US FDA clears passage for pharmacies to dispense abortion pills
Updated : 2 months, 2 weeks ago IST
The US Food and Drug Administration has, for the first time cleared a passage for certified pharmacies to dispense abortion pills in the United States, Al Jazeera reported on Tuesday.
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US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Ina
Updated : 2 months, 2 weeks ago IST
Mumbai (Maharashtra) [India], January 3 (ANI/PRNewswire): Datar Cancer Genetics announced today that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors. This is the thir
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Glenmark gets US drug regulator's nod for high BP medicine
Updated : 3 months ago IST
Glenmark's Nicardipine Hydrochloride capsules of 20 mg and 30 mg will be distributed in the US by Glenmark Pharmaceuticals US, according to a statement from Glenmark.
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China halts some Taiwanese food imports over ingredients labeling issue
Updated : 3 months ago IST
According to Taiwanese Food and Drug Administration (FDA) Director-General Wu Show-mei, all goods exported from Taiwan must be labeled with the ingredients and their percentage in the product.
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Alembic Pharma gets US regulator final nod for skin ointment - Desonide Cr
Updated : 3 months, 1 week ago IST
According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis U
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USFDA lists Sun Pharma's Halol unit under 'import alert'
Updated : 3 months, 1 week ago IST
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.
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