Unichem receives USFDA approval for Divalproex ER Tablets
Unichem Laboratories Limited is announce that it has received ANDA approval for its Divalproex Sodium Extended-Release ...
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Tag: usfda
Zydus receives final approval from USFDA for Dapagliflozin Tablets
Zydus has received final approval from the USFDA to market Dapagliflozin Tablets in the strengths of ...
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Strides receives USFDA approval for Amantadine Hydrochloride Softgel Capsules
Strides Pharma Science Limited today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. ...
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Dr.Reddy’s facility receives EIR from USFDA
Dr.Reddy's formulations manufacturing facilities (FTO 7 & FTO 9) at Duvvada, Visakhapatnam has received the Establishment ...
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US FDA publishes product-specific guidances to facilitate generic drug development
The FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and ...
Read moreDr.Reddy’s receives EIR from USFDA for API manufacturing plant of Middleburg, New York,
Dr.Reddy's inform that they have received the Establishment Inspection Report (EIR) from US FDA for the ...
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Lupin Receives Approval from U.S. FDA for Arformoterol Tartrate Inhalation Solution
Lupin Limited today announced that it has received approval from the United States Food and Drug ...
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Biocon receives approval of its ANDA for Posaconazole Delayed-Release tablets from the US FDA
Biocon Pharma Limited, a subsidiary of Biocon Limited, received approval of its ANDA for Posaconazole Delayed-Release ...
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US FDA Approves Treatment for adults with rare type of Anemia
FDA has approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis ...
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FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance ...
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