Page 22 - Usfda

Torrent Pharma Q3 net up by 18% to Rs 297 cr even as US revenues dip

India revenues grew 7% to stand at Rs 930 cr. Company's consolidated total revenue from operations fell marginally by under 1% to Rs 2,003 cr in Q3FY21

PE firm Advent International acquires 51% stake in ZCL Chemicals

ZCL is one of the fastest-growing manufacturers of specialty active pharmaceutical ingredients (APIs) and advanced intermediates

Alembic Pharma gets five observations from USFDA for Gujarat facility

Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat. "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Alembic Pharma said none of the observations were related to data integrity and were procedural in nature. "The company is preparing the response to the observations, which will be

Glenmark Pharma gets USFDA approval for nervous system stimulant drug

Glenmark Pharmaceuticals Ltd has been granted final approval by the United States Food and Drug Administration (USFDA) for Amphetamine Sulfate tablets USP

Strides Pharma Science arm gets USFDA nod for HIV treatment medicine

Strides Pharma Science said its step-down wholly-owned subsidiary, has received approval from the USFDA for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV

USFDA informs Biocon, Mylan of deferred action on biosimilar license plea

Biocon said its arm, Biocon Biologics, and Mylan have been informed by the USFDA of a deferred action on the biologics license application for a biosimilar to drug Avastin

Glenmark Pharma gets tentative nod from USFDA for blood thinning drug

Drug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules

USFDA panel recommends emergency use authorisation of Moderna Covid vaccine

The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna Covid-19 vaccine

India Coronavirus Dispatch: 90 infections 'missed' for one detected

A slowing spread of the virus, measures to ensure safety in vaccine development, an expanding digital divide, and more-news relevant to India's fight against Covid-19

US regulators approve genetically modified pig for food, drugs use

US regulators have approved a genetically modified pig for food and medical products, making it the second such animal to get the green light for human consumption

US FDA confirms 94.1% efficacy of Moderna vaccine, says it's safe

Publishes findings ahead of key review, paving the way for a second vaccine

USFDA to scrutinise Pfizer's coronavirus vaccine data for red flags

Pfizer's Covid-19 vaccine faces one final hurdle as it races to become the first shot greenlighted in the US: a panel of experts who will scrutinise the company's data for any red flags

Aurobindo Pharma gets USFDA approval for drug used to sedate patients

Drug major Aurobindo Pharma said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients

UK ready for roll-out; Pfizer CEO not certain if shot stops spread

US, China also set to start process of inoculating their citizens from this week

Alembic Pharma gets USFDA nod for pills to treat salt, water retention

Alembic Pharmaceuticals said it received approval from the US health regulator for Metolazone tablets, indicated for the treatment of salt and water retention caused by heart failure or kidney disease

Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug

Drug major Glenmark Pharma on Tuesday said it has received tentative approval from the US health regulator for Axitinib tablets, used in the treatment of kidney cancer. The tentatively approved product is the generic version of Inlyta tablets of PF Prism CV. Glenmark Pharmaceuticals Inc, USA has received tentative approval by the United States Food & Drug Administration (USFDA) for Axitinib tablets in the strength of 1 mg and 5 mg, the company said in a regulatory filing. Quoting IQVIA sales data for the 12 months ending October 2020, Glenmark Pharma said the Inlyta Tablets, 1 mg and 5 mg market achieved annual sales of approximately USD 518.8 million. Glenmark's current portfolio consists of 166 products authorised for distribution in the US market and 45 ANDA's pending approval with the USFDA.

India Coronavirus Dispatch: Situation remains grim in national capital

Covid may impact vision of some patients, ethical dilemma of denying vaccine to trial participants, UP artisans start selling online-news relevant to India's fight against the pandemic

Strides Pharma Science gets USFDA nod for generic Prednisone tablets

Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone tablets, prescribed for a variety of conditions, including allergies, respiratory illness and arthritis. The approval for Prednisone tablets by the US Food & Drug Administration (USFDA) granted to the company's step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, is for multiple strengths of 2.5 mg and 5 mg, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Deltasone tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co, it added. Citing IQVIA MAT September 2020 data, the company said the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately USD 30 million. "The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market," it ...

WHO advises doctors against using Gilead's remdesivir for treating Covid-19

The recommendation is a blow to Gilead's drug, which was one of the first thought to offer a meaningful benefit to coronavirus patients after a study showed it reduced their recovery time

USFDA approves first Covid-19 testing kit for home use; result in 30 mins

The US Food and Drug Administration said it had approved the first Covid-19 self-testing kit for home use that provides results within 30 minutes