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Tag: granules pharma

You Searched For "granules pharma"
Widely abused neurological drug formulations worth over Rs 5 crore seized in Punjab in 2024: Minister

Granules India arm gets USFDA nod for ADHD drug Lisdexamfetamine Dimesylate

Ruchika Sharma30 Jan 2025 2:30 PM IST
Hyderabad: Granules India Limited, a vertically integrated Indian pharmaceutical company, has announced that its wholly-owned foreign...
Alembic Pharma secures USFDA final nod for anticonvulsant drug Carbamazepine

USFDA nod to Granules India arm for ADHD treatment

Ruchika Sharma17 Dec 2024 1:30 PM IST
Hyderabad: Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign...
Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug Rivaroxaban

Granules India bags USFDA okay for Glycopyrrolate Oral Solution

Ruchika Sharma20 Aug 2024 3:39 PM IST
Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA)...
Granules India arm gets USFDA nod for Gout flares drug Colchicine

Granules India arm gets USFDA nod for Gout flares drug Colchicine

Ruchika Sharma30 April 2024 11:30 AM IST
Colchicine Capsules are indicated for prophylaxis of gout flares in adults.
Laurus Labs gets USFDA EIR for Atchutapuram facility

USFDA classifies Granules Pharma facility as Voluntary Action Indicated

Ruchika Sharma4 April 2024 3:00 PM IST
Hyderabad: Granules India has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has classified the facility of...
Granules Pharma facility gets 5 USFDA observations

Granules Pharma facility gets 5 USFDA observations

Ruchika Sharma16 Dec 2023 12:14 PM IST
Hyderabad: Granules India Limited has announced that the United States Food and Drug Administration (USFDA) has concluded a GMP inspection...
Granules India subsidiary bags USFDA nod for Sildenafil for Oral Suspension

Granules India subsidiary bags USFDA nod for Sildenafil for Oral Suspension

Ruchika Sharma4 Dec 2023 1:30 PM IST
Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

Granules Pharma successfully completes USFDA inspection with zero observations

Ruchika Sharma4 Aug 2023 11:45 AM IST
Hyderabad: Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, located in...
Granules Europe dissolves

Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets

Ruchika Sharma14 July 2023 11:09 AM IST
Acetaminophen and Ibuprofen Tablets are used for temporary relief for minor aches and pains due to: headache, toothache, backache, menstrual cramps,...
Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER

Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER

Ruchika Sharma24 Jan 2023 12:02 PM IST
Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
USFDA okays Granules Pharma Bupropion Hydrochloride ER Tablets

USFDA okays Granules Pharma Bupropion Hydrochloride ER Tablets

Ruchika Sharma4 Feb 2022 12:43 PM IST
Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug...
Granules India arm gets 3 USFDA observations for Chantilly facility

Granules India arm gets 3 USFDA observations for Chantilly facility

Ruchika Sharma31 Jan 2022 1:02 PM IST
Hyderabad: Granules India Limited announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in...
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