Page 28 - Usfda

Lupin gets EIR from USFDA for its manufacturing plant in Nagpur

The company's shares surged 4.14% to Rs 820.40 after they received the inspection report (EIR) from the US drug regulator

Coronavirus outbreak: Quick USFDA approvals for asthma drug makers

Cipla gets nod for drug from USFDA earlier than expected; Lupin in fray

China's recovery from coronavirus outbreak, drug demand lift pharma funds

Easing of supply chain issues, hydroxychloroquine opportunity boost sentiments

Zydus Cadila gets final nod from USFDA to market generic seizures drug

The group now has 283 approvals and has so far filed over 386 abbreviated new drug applications

Top headlines: Biz sentiment sinks to record low, Moody's outlook on banks

Business Standard brings to you the top headlines of the day

India may soon ease some drug export curbs under US pressure: Report

Imports from India accounted for 24% of medicines and 31% of medicine ingredients to the United States in 2018, according to the US Food and Drug Administration

USFDA approves AstraZeneca's combo treatment for lung cancer patients

The combo treatment has been approved in the United States for adult patients with extensive-stage small cell lung cancer, the company said

Lupin gets EIR from USFDA for Florida-based inhalation research centre

The Center at Coral Springs, Florida, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.

USFDA approves limited use of antimalarial drugs to treat Covid-19 patients

Two US medical bodies -- the National Institutes of Health and the Biomedical Advanced Research and Development Authority -- are currently working to plan such trials

Sun Pharma's product approvals at risk as USFDA labels Halol plant as OAI

Earlier in December, the plant had been issued Form 483 by USFDA with eight observations

Test that can detect coronavirus in 5 minutes; courtesy Abbott Labs

Abbott to supply 50,000 tests a day starting April 1

Top headlines: FM's relief package for poor, Cipla gets USFDA nod, and more

Business Standard brings to you the top headlines of the day

Pharma major Cipla gets USFDA nod for generic oral acid reflux drug

According to IQVIA, Nexium and its generic equivalents had US sales of around $70 million for the 12 months ended November 2019

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

The product is a generic version of AstraZeneca AB's Farxiga tablets

Ipca and Cadila Healthcare gear up to make drug for coronavirus

Ipca is the biggest producer of the drug. Cadila Healthcare, based in Ahmedabad, too is a major player

Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said

US approves anti-malarial drug to treat COVID-19, says Donald Trump

But the FDA Commissioner Stephen Hahn later indicated that, while the drug has not yet been formally approved, access to it was being expanded so that authorities could gather more data

Dr Reddy's launches generic Ziprasidone Mesylate for injection in US

It's the therapeutic generic equivalent of Geodon Injections

Alkem Laboratories gets EIR from USFDA for manufacturing facility at Baddi

The USFDA has now issued an EIR for the manufacturing facility, it added.

Biocon, Mylan win patent case for insulin device against Sanofi in US

Development takes Biocon a step closer to commercialise its glargine biosimilar Semglee in America