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USFDA inspects Alembic Pharma

USFDA inspects Alembic Pharma New Delhi: Drug firm Alembic Pharmaceuticals said the US health regulator has conducted an...

US pharma Cos get more FDA ‘warnings’ than Indian firms

Mumbai: The Indian pharma industry, which is rapped for poor manufacturing practices globally, seems to be cleaning up its act, at least in relative...

Biocon: USFDA concludes with zero observations

NEW DELHI: Biocon said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.

Lupin gets 5 observations from USFDA

Lupin gets 5 observations from USFDA Drug firm Lupin said it has received five observations from the US health regulator after inspection of...

Strides gets USFDA nod for anti-allergic drug

Strides gets USFDA nod for anti-allergic drug NEW DELHI: Strides Pharma Science on Thursday said it has received approval from the...

USFDA approves Cocaine HCl nasal solution 4%

Philadelphia USFDA approves Lannett's branded anesthetic product, cocaine HCl nasal solution 4% ...

Alembic gets USFDA nod for Tizanidine HCL capsules

Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity New Delhi: Drug firm Alembic Pharmaceuticals...

Draft guidelines finalized on post-approval changes in drugs

Draft guidelines finalized on post-approval changes in drugs The Dr Venkateswarlu headed sub-committee, constituted by the Drugs Controller...

Alembic gets USFDA nod for Vilazodone HCL Tab

Alembic gets USFDA nod for Vilazodone HCL Tab used to treat depression. New Delhi: Drug firm Alembic Pharmaceuticals on Monday...

Granules recalls over 2.3 cr Ranitidine tablets

Hyderabad: City-based pharma player Granules India Ltd has initiated a voluntary recall of over 2.3 crore tablets of Ranitidine 150 mg in the US market.

New talc testing standards amid asbestos

(Reuters) - An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject...

Lupin gets 2 observations from USFDA

Lupin gets 2 observations from USFDA Drug firm Lupin on Saturday said it has received two observations from the US health...

USFDA approves Merck’s Keytruda for bladder cancer

USFDA approves Merck's Keytruda for bladder cancer The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co...

USFDA approves Abbott’s HeartMate 3 heart pump

USFDA approves Abbott's HeartMate 3 heart pump to help patients avoid open heart surgery Abbott announced that the...

Glenmark gets USFDA nod for generic Exjade tablets

Glenmark gets USFDA nod for generic Exjade tablets Glenmark Pharmaceuticals Inc, USA has received final approval from the United...

USFDA red flags GPT Pharmaceuticals

USFDA red flags GPT Pharmaceuticals for significant violations at Hyderabad unit New Delhi: The US health regulator has red...

Aurobindo Pharma recalls Mirtazapine tablets in US

New Delhi: Aurobindo Pharma recalls Mirtazapine tablets in US. Aurobindo Pharma USA Inc said it is voluntarily recalling Mirtazapine tablets, used for the treatment of major...

Indoco gets US FDA nod for febuxostat tablets

Indoco gets US FDA nod for febuxostat tablets. Indoco Remedies received final approval of its Abbreviated new drug application...

Dr Reddy’s launches generic hypotensive injection

NEW DELHI: Dr Reddy's launches generic hypotensive injection in US. Drug firm Dr Reddy's Laboratories said it has launched in...

Sol Gel’s acne cream reduces marks

Sol Gel's acne cream reduces marks in two late studies. Sol Gel Technologies Ltd said its lead acne drug...

USFDA nod to Lynparza to treat pancreatic cancer

USFDA nod to AstraZeneca and Merck's Lynparza to treat pancreatic cancer. AstraZeneca and Merck & Co's ovarian cancer drug, Lynparza, received...

Alembic gets USFDA nod for generic glaucoma drug

New Delhi: Drug firm Alembic Pharmaceuticals said it has received final approval from the US health regulator to market Travoprost Ophthalmic Solution, used in treatment...

Granules India gets USFDA nod for Loratadine tablets

New Delhi: Granules India on Tuesday said the US health regulator has given its approval to the abbreviated new drug Application filed by the drug firm...

Indian and global regulatory systems

Stressing that there is a need to bring drastic changes in the Indian regulatory system by regulatory convergence and greater harmonisation to...

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