USFDA Archives - Page 9 of 23

Granules India gets EIR from USFDA for Jeedimetla facility

adminMay 16, 2018

by adminMay 16, 201801130

Granules India has received Establishment Inspection Report (EIR), from the US health regulator for facility in Telangana. The US Food and Drug Administration inspected Jeedimetla facility...

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USFDA concludes inspection of J B Chemicals Panoli facility

adminMay 14, 2018

by adminMay 14, 20180800

The US health regulator has completed inspection of J B Chemicals and Pharmaceuticals Panoli facility, in Gujarat with two minor observations. In a BSE filing the...

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Glenmark Pharma gets approval for skin treatment cream from USFDA

adminMay 11, 2018

by adminMay 11, 20180755

Glenmark Pharmaceuticals has received final approval for the generic version of Temovate cream used to treat inflammation and itching caused by a number of skin conditions,...

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Cadila Healthcare gets final approval from USFDA for Carbidopa tablets

adminMay 10, 2018

by adminMay 10, 20180873

Cadila Healthcare has received final approval to market Carbidopa tablets,25 mg from USFDA. The drug is used with a combination levodopa/carbidopa product to treat symptoms of...

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USFDA issues 7 observations to Biocon’s Bengaluru facility

adminMay 3, 2018

by adminMay 3, 20180858

The US health regulator, has issued 7 observations to Biocon’s sterile drug product manufacturing facility in Bengaluru, after inspection. In a filing to the BSE the...

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Zydus Cadila gets USFDA approval to market 2 drugs

adminApril 26, 2018

by adminApril 26, 20180889

Zydus Cadila has received final approval to market two drugs, from the US health regulator. The company stated that, it has received approval to market Methylprednisolone tablets USP...

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Lupin gets USFDA approval to market Tetrabenazine tablets

adminApril 23, 2018

by adminApril 23, 20180759

Lupin has received final approval to market its Tetrabenazine tablets, from the US health regulator. It is used for treating involuntary movements associated with Huntington’s disease....

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USFDA completes Unichem’s Ghaziabad plant inspection

adminApril 21, 2018

by adminApril 21, 20180993

The US health regulator has completed the inspection of Unichem’s Laboratories, Ghaziabad facility in Uttar Pradesh and the regulator has not issued any observation to it....

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Glenmark gets USFDA nod for generic version of Temovate Topical

adminApril 20, 2018

by adminApril 20, 201801142

Glenmark Pharmaceuticals has received final approval for generic version of Temovate Topical Solution, from the US health regulator. It is used to treat certain scalp and skin...

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Zydus gets USFDA approval to market Diclofenac Sodium Topical Solution

adminApril 19, 2018

by adminApril 19, 20180807

Zydus Cadila has received final approval to market Diclofenac Sodium Topical Solution, from the US health regulator. It is used for treating signs and symptoms of osteoarthritis of...

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Tag : USFDA

Granules India gets EIR from USFDA for Jeedimetla facility

USFDA concludes inspection of J B Chemicals Panoli facility

Glenmark Pharma gets approval for skin treatment cream from USFDA

Cadila Healthcare gets final approval from USFDA for Carbidopa tablets

USFDA issues 7 observations to Biocon’s Bengaluru facility

Zydus Cadila gets USFDA approval to market 2 drugs

Lupin gets USFDA approval to market Tetrabenazine tablets

USFDA completes Unichem’s Ghaziabad plant inspection

Glenmark gets USFDA nod for generic version of Temovate Topical

Zydus gets USFDA approval to market Diclofenac Sodium Topical Solution

EquityPandit