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About 442 results for "usfda"

Zydus Cadila receives USFDA nod to market fluconazole tablets
Money Control

Cadila Health: Zydus gets USFDA nod for Phase II clinical tria...

Zydus Cadila announced that the USFDA has approved the group�s plan to initiate a Phase 2 clinical trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC) of the liver. Money Control, 10 hours ago
Zydus gets USFDA nod for phase II trials of liver drug Business Standard, 6 hours ago
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234 images for usfda

Money Today, 1 day ago
Money Control, 2 days ago
Money Control, 6 days ago
Money Control, 1 week ago
DNA, 1 week ago
India.com, 2 weeks ago
Money Control, 2 weeks ago
Money Control, 2 weeks ago
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Pharmaceutical Tech.com, 2 weeks ago

Dr Reddy's receives 3 USFDA observations for Miryalaguda plant

The company didn’t explain the nature of these observations. Miryalaguda plant was one among the three plants for which the company got US drug regulator warning letter in November 2015.
 Money Control1 day ago DRL gets 3 USFDA observations for Miryalaguda facility  Myiris1 day ago
Money Control

Biocon and Mylan get USFDA approval to jointly develop biologic product

The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace The post Biocon and Mylan get USFDA approval to jointly develop biologic product appeared first on Firstpost .
 First Post.com6 days ago FDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim  DNA6 days ago USFDA accepts Mylan's application for proposed biosimilar  Business Standard1 week ago USFDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim  Business Standard6 days ago
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Money Control

Cadila gains on resolution of its Moraiya plant warning letter

The company said it did not receive any observations from USFDA for its Moraiya facility, indicating successful resolution of the warning letter and thereby expects major boost to its US business.
 Money Control1 week ago USFDA inspects Cadila Healthcare's Moraiya facility  Money Control1 week ago Meeting manufacturing norms, says Cadila Healthcare after USFDA inspection  DNA1 week ago Cadila shares extend gains; surge nearly 5%  Business Standard6 days ago
DNA

Lupin gets USFDA nod for generic cough relief oral solution

Drug firm Lupin has received approval from the US health regulator for generic Hydrocodone Bitartrate and Homatropine Methylbromide oral solution used for providing relief of cough.
 DNA1 week ago Lupin receives final USFDA approval for Moxifloxacin Hydrochloride tablets  Money Control1 week ago Ajanta Pharma gets USFDA observation for Paithan facility  DNA2 weeks ago Ajanta Pharma: Updates on USFDA inspection of Paithan facility  Money Control2 weeks ago
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Aurobindo Pharma clears USFDA inspection for Unit-11

The Unit-11 plant produces non-antibiotic active ingredients, is used for both the captive purpose of Aurobindo’s formulation manufacturing and for supplies to external customers.
 Money Control2 days ago Aurobindo's Hyd unit getting form 483 a non-event: Surajit Pal  Money Control2 months ago
Money Today

Dr Reddy's Miryalaguda facility gets 3 USFDA observations

Drug firm Dr Reddy's Laboratories today said the US health regulator has made three observations after completing inspection of its Miryalaguda facility.
 DNA2 days ago USFDA concludes inspection of Dr Reddy's Miryalaguda facility  Money Today1 day ago

Sensex gains 150 pts, Nifty holds 8800; HDFC Bank off day's high

Sun Pharma gained for second consecutive session, up 2.75 percent on hopes of early USFDA clearance to its Halol facility, especially after Cadila did not get any observations for its Moriaya facility. Wockhardt also rose 3 percent.
 Money Control6 days ago Sensex up over 250 pts; Indiabulls Hsg, IOC soar; SBI BoI dip  Money Control6 days ago Nifty holds 8800, Sensex strong; IT stocks down on profit taking  Money Control6 days ago
DNA

Biocon at new high; FDA accepts BLA for biosimilar Pegfilgrastim

Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
 Money Control6 days ago Biocon up 3% as USFDA accepts Trastuzumab license application  DNA1 month ago Biocon hits new high after USFDA accepts cancer drug biosimilar application  Business Standard1 month ago Biocon at new high as USFDA accepts application for cancer drug  Money Control1 month ago
Money Control

Dishman Pharma gets USFDA report on closure of inspection of its Gujarat facility

Drug firm Dishman Pharmaceuticals and Chemicals Ltd has received an Establishment Inspection Report (EIR) from the US health regulator on closure of inspection of its Bavla facility in Gujarat.“Th...
 Business Line3 weeks ago Dishman Pharma rises 4%, Bavla facility receives EIR from USFDA  Money Control3 weeks ago Dishman Pharmaceuticals and Chemicals provides updates on USFDA inspection  India Infoline3 weeks ago Dishman Pharma receives EIR from USFDA for Bavla facility  Money Control3 weeks ago
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