Anda

The first order impact will be a slow market share gain from innovators after a generic launch

Lupin receives US FDA approval for generic anti-fungal drug

The product will be manufactured at Lupin’s Pithampur facility in India. Fluconazole tablets USP had estimated annual sales of $43 million in the US according to IQVIA MAT data in July 2023

Alembic receives US tentative approval for Dasatinib tablets

Dasatinib tablet is prescribed for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase.

Cipla gets final nod from USFDA for migraine treatment nasal spray

"It has received final approval for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate nasal spray 4mg/mL from the United States Food and Drug Administration (USFDA) with a competitive generic therapy (CGT) designation," the company said in a filing to BSE.

JB Chemicals Gujarat unit passes USFDA inspection with one observation

The company's solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, has successfully passed periodical inspection by USFDA with one minor procedural observation, JB Chemicals and Pharmaceuticals said in a filing to BSE.

Strides to acquire 18 abbreviated new drug applications from Pharmaceutics International, Inc

"Strides...announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International, Inc (Pii) to acquire 18 ANDAs for the US market," the company said in a filing to BSE.

Granules Pharmaceuticals, Inc gets USFDA nod for Colchicine tablets

Familial mediterranean fever is a genetic disorder that causes recurrent episodes of fever that are typically accompanied by pain in the abdomen, chest, or joints.

Will 2020 be the year of the pharma sector?

The pharma index valuation is trading at a discount to the broad index for the first time in five years.

Unichem Labs gets USFDA nod to market anxiety disorder tablets

The company has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) to market its Buspirone Hydrochloride tablets USP, in the strengths of 5 mg, 10 mg, 15 mg, and 30 mg, Unichem Laboratories said in a BSE filing.

Alembic Pharma gets USFDA nod for 2 generic products

The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.

Lupin gets 5 observations from USFDA for Pithampur Unit-3 facility

The pre-approval inspection (PAI) was triggered after the company filed Tiotropium dry powder inhalation (DPI) abbreivated new drug application (ANDA).

Glenmark gets USFDA nod for contraceptive drug

"Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP and Ferrous Fumarate tablets, 1 mg/20 mcg, the generic version of Minastrin 24 Fe tablets," the company said in a BSE filing.

Zydus Cadila gets USFDA nod for blood pressure treatment drug

The approval by the US Food and Drug Administration (USFDA) is for multiple Candesartan Cilexetil and hydrochlorothiazide tablets of 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mg, Cadila Healthcare said in a BSE filing.

Zydus gets USFDA nod for seizure, migraine drug

The company has received approval from the US Food and Drug Administration (USFDA) to market the drug in strengths of 25 mg, 50 mg and 100 mg, Zydus Cadila said in a BSE filing.

Granules US partner gets ANDA approval for heart drug

According to a statement issued by Granules, it has an exclusive tie up with USpharma to market and distribute four drugs of the latter, including Prasugrel (5 mg and 10 mg).

Glenmark looks to file up to 25 product applications annually

While acknowledging strict regulatory environment, he added that the company's pipeline of specialty products, to be rolled out over the next 3-4 years, is expected to act as a defence against generic price erosion and increase in competition, and boost profitable growth.

USFDA hikes fee for processing ANDA by $1 lakh for FY18

According to a notification on USFDA's website, fee for Drug Master File was reduced to USD 47,829 for 2017-18 from USD 51,140 in the last fiscal.

Wockhardt's antibiotic injection gets USFDA nod

The company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxacillin injections in the strengths of 1 gm and 2 gm, Wockhardt said in a filing to the BSE.

Alembic Pharma gets USFDA go-ahead for anti-bacterial drug

"The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Doxycycline capsules USP 75 mg and 100 mg," Alembic Pharmaceuticals said in a BSE filing today.

Cipla eyes filing over 20 ANDAs in US this fiscal

In the last financial year, the company had filed 32 abbreviated new drug applications (ANDAs) in the US.

Zydus Cadila gets USFDA nod for its ulcerative colitis drug

The company has received final approval from the United States Food and Drug Administration (USFDA) for Mesalamine delayed-release tablets in the strength of 800 mg, Zydus Cadila said in a statement.

Jubilant Life Sciences gets USFDA nod for anti-depressive drug

"Jubilant Pharma Ltd...has received abbreviated new drug application (ANDA) final approval for Bupropion Hydrochloride extended-release tablets USP (XL), 150 mg and 300 mg," Jubilant Life Sciences said in a BSE filing.

Alembic gets tentative USFDA nod for erectile dysfunction drug

"The company has received tentative approval from the United States Food and Drug Administration (USFDA) for its ANDA for vardenafil hydrochloride orally disintegrating tablets," Alembic Pharmaceuticals said in a BSE filing.

Alembic Pharma gets USFDA nod for anti-influenza drug

"The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Amantadine Hydrochloride capsules USP 100 mg," Alembic Pharmaceuticals said in a BSE filing.

Jubilant gets USFDA nod for generic hypertension drug

Jubilant Pharma Ltd, a wholly-owned subsidiary of the company, has received abbreviated new drug application (ANDA) final approval for Amlodipine and Olmesartan Medoxomil in various strengths from the US Food and Drug Administration (USFDA), Jubilant Life Sciences said in a statement.