Cipla’s Indore plant under US FDA scanner
As many as nine issues have been raised by the regulator under 'Form 483' regarding manufacturing practices in the plant Cipla's…
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Browsing Tag
US FDA
Jubilant Life Sciences gets US FDA nod
The drug is indicated for the acute treatment of migraine in adults and paediatric patients Jubilant Life Sciences has received…
US FDA bans import from Megafine Pharma’s Maharashtra facility
The import alert on the drugs made at the facility entails 'detention without physical examination of drugs from firms which have…
Aurobindo Pharma receives US FDA Approval for Alzheimer’s drug
The approved product has an estimated market size of $1.23 billion according to IMS Aurobindo Pharma has received the final…
Unichem Labs receives US FDA approval for memantine hydrochloride tabs
Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type
DRL launches esomeprazole magnesium delayed-release capsules
The 20 mg and 40 mg capsules are available in bottle count size of 30 Dr Reddy’s Laboratories (DRL) has launched esomeprazole…
US FDA reverses NDA nod for Sun Pharma’s anti epileptic drug
SPARC had earlier received a final approval from US FDA in March 2015 for this product Sun Pharma Advanced Research Company…
Jubilant Life Sciences gets US FDA nod for anti-migraine tablets
The company's drug is a generic version of AstraZeneca's Zomig-ZMT tablets, which is used for acute treatment of migraine…
Granules India gets US FDA nod for generic Ibuprofen tabs
The tablets are used to treat fever, pain or inflammation in the US market Drug maker Granules India has received approval from…
Sun Pharma to acquire InSite Vision
Strengthens branded ophthalmic portfolio in US Sun Pharmaceutical Industries' subsidiary has entered into an agreement and plan…