Search For "united states food and drug administration"
Zydus receives approval from the US drug authority to produce cholesterol-
Updated : 10 months, 2 weeks ago IST
Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets.
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Nureca Limited's Manufacturing Subsidiary Secures US FDA Registration
Updated : 11 months ago IST
Mumbai (Maharashtra) [India], April 12: Nureca Technologies Private Limited, the manufacturing subsidiary of Nureca Limited, has successfully completed its annual registration with the United States Food and Drug Administration (US FDA). The company's manufacturing facility in Mohali, Punjab
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Atul Bioscience Ltd Received EIR from the US FDA for its Ambernath Facilit
Updated : 1 year, 7 months ago IST
Mumbai (Maharashtra) [India], August 12: Atul Bioscience Ltd (ABL), a 100 per cent subsidiary company of Atul Ltd, received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility situated in Ambernath, Maharashtra.
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Rusan Pharma's API Plant in Ankleshwar Receives (India) USFDA GMP Approval
Updated : 1 year, 7 months ago IST
Ankleshwar (Gujarat) [India], July 22: RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of addiction treatment and pain management, recently announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Prac
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US FDA inspection closed at its Injectable Facility with Zero 483 observat
Updated : 1 year, 9 months ago IST
According to the stock market filing with the National Stock Exchange, the U.S. FDA carried out the inspection between June 10 to June 13, 2024, and concluded with zero 483 observations. The pharma major said in its filing, "The United States Food and Drug Administration (U.S. FDA) has compl
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Cipla secures USFDA approval for pancreatic disease injection, shares surg
Updated : 1 year, 9 months ago IST
Mumbai-headquartered pharma major, Cipla's US arm has secured final approval from the United States Food and Drug Administration (USFDA) for its Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, and 60 mg/0.2 mL.
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Ajinomoto Bio-Pharma Services receives FDA approval for High Potency Fill
Updated : 2 years, 10 months ago IST
San Diego (California) [US], April 19 (ANI/PRNewswire): Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the
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Zydus receives final approval from US regulator for Azithromycin tablets
Updated : 2 years, 11 months ago IST
Azithromycin is prescribed to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
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Lupin gets US regulator's nod for Prasugrel tablets used in heart ailments
Updated : 3 years, 2 months 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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USFDA lists Sun Pharma's Halol unit under 'import alert'
Updated : 3 years, 3 months 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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Curadev Pharma receives FDA 'Study May Proceed' Letter for its Investigati
Updated : 3 years, 3 months ago IST
Boston (Massachusetts) [US]/ Noida (Uttar Pradesh) [India], December 6 (ANI/PRNewswire): Curadev Pharma, a small molecule drug discovery and development company focused on the generation of novel therapeutics for the treatment of intractable diseases such as cancer has received a Study May P
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Zydus receives final approval from USFDA to market Colestipol Hydrochlorid
Updated : 4 years ago IST
Ahmedabad (Gujarat) [India], March 15 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid), said the pharmaceutical company on Monday.
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