The Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA), has expressed ...

The USFDA conducted an inspection at Unit-I, a formulation manufacturing facility of the company’s wholly owned subsidiary, ...

The recent approval enables Zydus Lifesciences to produce and sell Apalutamide Tablets, 60 mg (a generic equivalent of Erleada) in the United States. Apalutamide is an androgen re ...

The U.S. Food and Drug Administration (USFDA) announced sweeping expansion of unannounced inspections at foreign manufacturing facilities, a move expected to significantly impact pharmaceutical ...

Strides Pharma Science said the USFDA completed a routine cGMP inspection at its flagship Bengaluru facility from May 12 to ...

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Clopidogrel Tablets USP 75mg, which is being launched. Clopidogrel Tablets USP ...

Developed using STEERLife's proprietary FragMelt™ continuous processing platform, this approval represents a breakthrough in pharmaceutical manufacturing. The platform enables a sustainable, ...

Bengaluru: The U.S. ​FDA said on ​Thursday it would hold a meeting of ​outside experts next month to review Moderna's ...

The approval granted by the US Food and Drug Administration (USFDA) for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a ...

New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures. The company has received approval from the US ...

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator for its generic version of risperidone for extended-release injectable suspension, used in the treatment ...

Drug major Cipla on Wednesday said it has received approval from the US health regulator to market a generic medication used to treat acromegaly and other conditions. The company has received the ...