Tag: Alembic Pharmaceuticals
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┬аLtd on Tuesday said its joint venture,┬аAleor Dermaceuticals┬аLtd (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...