US health regulator to soon lift import alert imposed on Divi’s Laboratories
Divi’s said it has taken up appropriate remediation measures to address the concerns raised by USFDA
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Browsing Tag
US FDA
Lupin receives FDA approval for generic Flucytosine caps
Flucytosine capsules is a generic version of Valeant Pharmaceuticals International's Ancobon Capsules
Jubilant Life Sciences receives US FDA approval for Bupropion Hydrochloride tablets
Bupropion Hydrochloride is the generic version of Wellbutrin XL of Valeant and is used for the treatment of major depressive…
30 Per cent of ANDAs approved by the US FDA in the year 2016 are from India
The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is working on a zero-dependent manufacturing mechanism to…
Sun Pharma ties up with Samsung BioLogics
Samsung BioLogics will manufacture Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of…
Unichem gets EIR from US FDA for Goa plant
The receipt indicates successful closure of the inspection and queries raised during the audit
Zydus Cadila gets US FDA nod to market anti-obesity drug
The drug will be produced at the group’s formulations manufacturing facility at Moraiya in Ahmedabad
Zydus Cadila to market oxybutynin chloride tablets
Oxybutynin is used to treat overactive bladder and urinary incontinence
Glenmark Pharma receives tentative ANDA approval for solifenacin succinate tabs
According to IMS Health, the Vesicare tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.1 billion
FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs
Updated recommendations are provided for the statistical analysis of adhesion scores and results
The FDA has published the draft…