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USFDA issues Form 483 with 2 observations to Alembic, Gujarat

Ahmedabad: Alembic Pharmaceuticals Ltd on Friday said the US health regulator has issued a Form-483 with two minor procedural observations following inspection of its...

USFDA gives approval for Lenalidomide capsules

Aurobindo Pharma said its wholly-owned subsidiary firm Eugia Pharma Specialities has received final approval from the US Food and Drug Administration (USFDA)...

USFDA gives final approval for Prazosin Hydrochloride capsules

The drug maker Alembic Pharmaceuticals announced that it has received final approval from US Food and Drug Administration (USFDA) for its...

USFDA gives final approval to this breast cancer injection

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new...

USFDA gives approval for Fulvestrant injection

Drug major Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated...

USFDA gives nod for Nifedipine ER tablets

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA)...

USFDA completes inspection of Alembic with no observations

The drug maker Alembic Pharmaceuticals announced that its bioequivalence facility located in Vadodara has completed the United States Food and Drug Administration...

USFDA issues Form 483 with 2 observation to Alembic

New Delhi: Alembic Pharmaceuticals said the US health regulator has issued Form 483 with two observations for its injectable facility at Karkhadi in Gujarat,...

USFDA gives tentative nod to Alembic for Macitentan Tablets 10 mg

Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New...

USFDA gives nod to Alembic Pharmaceuticals for anti fungal drug

Alembic Pharmaceuticals Ltd on Tuesday said its joint venture, Aleor Dermaceuticals Ltd (Aleor), has received final approval from the US health regulator for its generic...

USFDA gives nod to Alembic Pharma for Doxycycline Hyclate tablets

Alembic Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for doxycycline...

Alembic gets USFDA tentative nod for drug for high BP

Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for...

USFDA gives final nod to Alembic for Formoterol Fumarate inhalation solution

Alembic Pharmaceuticals today announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New...

Aleor gets USFDA final approval for Metronidazole gel

Alembic Pharmaceuticals today announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA)...

Alembic gets USFDA nod for Clomipramine HCL Capsules

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for...

Alembic gets USFDA final nod for Erlotinib Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Alembic gets USFDA nod for Nitrofurantoin Capsules USP

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Aleor gets USFDA nod for Testosterone Topical Solution

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for...

Alembic gets USFDA nod for depression treatment drug

Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Doxepin Hydrochloride Capsules, used to treat depression and anxiety.

Sun Pharma, Alembic recall products in the US market

Sun Pharma, Alembic recall products in the US market New Delhi: Leading drug makers Sun Pharma and Alembic Pharmaceuticals are recalling different products...

Aleor gets tentative USFDA nod for drug for topical treatment

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for...

Aleor gets USFDA nod for drug for cutaneous candidiasis treatment

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for...

Aleor Dermaceuticals gets USFDA nod for Testosterone Gel

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for...

Alembic gets USFDA approval for Asenapine Sublingual Tablets

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual...

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