Monday, March 10, 2025 | 06:34 PM ISTहिंदी में पढें
Business Standard
Notification Icon
userprofile IconSearch

Page 14 - Usfda

Policy flip-flops may puncture India's image as 'pharmacy of the world'

India supplies almost 20 per cent of the medicines consumed by the world. Every third tablet in the US market is from India

Policy flip-flops may puncture India's image as 'pharmacy of the world'
Updated On : 01 Jul 2020 | 10:54 PM IST

Sequoia-backed Qure.ai gets USFDA nod for CT scan, first for Indian AI firm

American regulator's decision covers four critical abnormalities identified by Qure.ai's emergency room product namely intracranial bleeds, mass effect, midline shift, and cranial fractures

Sequoia-backed Qure.ai gets USFDA nod for CT scan, first for Indian AI firm
Updated On : 01 Jul 2020 | 7:58 PM IST

USFDA to release guidance on Covid-19 vaccine approval: Report

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials

USFDA to release guidance on Covid-19 vaccine approval: Report
Updated On : 30 Jun 2020 | 7:44 PM IST

Zydus Cadila gets USFDA nod to market generic antihistamine tablets

The drug will be manufactured at the group's manufacturing facility in Ahmedabad

Zydus Cadila gets USFDA nod to market generic antihistamine tablets
Updated On : 24 Jun 2020 | 2:52 PM IST

USFDA removes partial lifting of import on API facility at Ratlam: Ipca Lab

USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa

USFDA removes partial lifting of import on API facility at Ratlam: Ipca Lab
Updated On : 24 Jun 2020 | 12:49 PM IST

Shot of Hope: Equal access a hurdle after race to coronavirus vaccine

The second of a two-part series examines challenges linked to IPR and monopoly once Covid-19 vaccine is created

Shot of Hope: Equal access a hurdle after race to coronavirus vaccine
Updated On : 23 Jun 2020 | 1:01 AM IST

Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets

The tablet is the generic of Janssen Pharmaceuticals Inc's reference listed drug product Xarelto

Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets
Updated On : 22 Jun 2020 | 4:36 PM IST

Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi

The USFDA had issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc for emergency use of remdesivir for the treatment of Covid-19 patients

Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi
Updated On : 21 Jun 2020 | 10:36 PM IST

Unichem, Lupin recall high blood pressure drugs from US over quality issues

The specified batch, which is being recalled, has been manufactured at Unichem's Goa-based facility

Unichem, Lupin recall high blood pressure drugs from US over quality issues
Updated On : 21 Jun 2020 | 1:30 PM IST

Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US

The site has received certifications from the Food and Drug Administration and European Medicines Agency

Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US
Updated On : 20 Jun 2020 | 5:02 PM IST

Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%

Cadila has also been working on a DNA vaccine to fight Covid-19, which is currently in the animal testing stage

Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%
Updated On : 19 Jun 2020 | 11:02 PM IST

Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment

The product was indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, Alembic Pharma said

Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment
Updated On : 19 Jun 2020 | 3:21 PM IST

Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis

The capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis

Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis
Updated On : 19 Jun 2020 | 12:31 PM IST

Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region

One of the company's wholly-owned subsidiaries and Hikma Pharmaceuticals have entered into the agreement for Ilumya, Sun Pharma said in a filing to BSE

Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region
Updated On : 15 Jun 2020 | 2:31 PM IST

Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India

Dr Reddy's would need to scale up manufacturing and obtain regulatory approval for marketing of this drug in respective countries, the company said

Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India
Updated On : 13 Jun 2020 | 3:48 PM IST

Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila

Indian drug maker to get know-how from Gilead Sciences Inc, to manufacture the API for Remdesivir, make the finished product and market it in 127 countries, including India

Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila
Updated On : 13 Jun 2020 | 2:30 AM IST

Biocon gets a shot in the arm with FDA approval for insulin glargine

The drug will be major contributor in the firm's bid to reach $1 billion revenue target by FY22, says biologics CEO Hamacher

Biocon gets a shot in the arm with FDA approval for insulin glargine
Updated On : 12 Jun 2020 | 8:08 PM IST

US FDA grants orphan drug status to mexiletine hydrochloride: Lupin

The Mumbai-based company's drug NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders

US FDA grants orphan drug status to mexiletine hydrochloride: Lupin
Updated On : 08 Jun 2020 | 12:57 PM IST

Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules

Atazanavir, an antiretroviral drug, is used to treat Human Immunodeficiency Virus (HIV-1) infection incombination with other antiretroviral drugs

Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules
Updated On : 05 Jun 2020 | 3:38 PM IST

Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir

The USFDA granted remdesivir an emergency use authorization for the treatment of hospitalized patients with severe Covid-19

Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir
Updated On : 02 Jun 2020 | 10:43 PM IST