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U.S. #FDA completes inspection at #UnichemLaboratories' #Goa formulation facility, issues 5 observations: Exchange filing
U.S. #FDA inspection at #ZydusLifesciences' Ahmedabad transdermal manufacturing site closes with 2 observations: Exchange filing
#AartiDrugs' manufacturing unit Pinnacle Life Science gets EIR from U.S. #FDA, successful closure of inspection.
#AlembicPharmaceuticals gets U.S. #FDA final approval for Nelarabine injection: Exchange Filing.
U.S. #FDA inspection at #GlandPharma's #Hyderabad facility closes with 3 observations: Exchange filing
U.S. #FDA inspection at #AurobindoPharma's arm's #Bhiwadi manufacturing facility closes with 'Official Action Indicated' classification
U.S. #FDA inspection at #AurobindoPharma's arm's #Bhiwadi manufacturing facility closes with 'Official Action Indicated' classification: Exchange filing
U.S. #FDA inspection at #FDC's #HimachalPradesh manufacturing plant closes with zero observations: Exchange filing
#ZydusLifesciences gets U.S. #FDA approval to market Scopolamine Transdermal System.
#AlembicPharma gets U.S. #FDA establishment inspection report for #Panelav facility.
#GranulesIndia receives approval from U.S. #FDA for tablets that treat major depressive disorders.
#FDA classification won't affect ongoing manufacturing or sales: #Granules India
#AurobindoPharma: U.S. #FDA inspection closes with 2 observations at arm Apitoria Pharma: Exchange Filing.
#Lupin gets approval from U.S. #FDA for ANDA for Emtricitabine and Tenofovir Alafenamide Tablets.
#AartiDrugs: U.S. #FDA concludes inspection and issues EIR for Tarapur API facility: Exchange Filing.
#Biocon gets EIR with 'Voluntary Action Indicated' status from U.S. #FDA for #Karnataka API facility.
#ZydusLifesciences announces receiving approval from the U.S. #FDA for the Dasatinib tablets.
#JustIn | #ZydusLife’s US arm announces #FDA acceptance of CUTX-101 NDA resubmission

Alert: CUTX-101 (#CopperHistidinate) is used to treat patients with #Menkes disease
#JustIn | #AlembicPharma gets US #FDA final nod for Efinaconazole Topical Solution

👉#Efinaconazole indicated for the topical treatment of #Onychomycosis

👉Efinaconazole has an estimated market size of $500 Million