Live Breaking News & Updates on Usfda

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National News: Ocugen files Covaxin IND application with USFDA, seeks nod for Phase-3 trial in US | India News – Rashtra News

Ocugen files Covaxin IND application with USFDA, seeks nod for Phase-3 trial in US | India News - Rashtra News : Rashtra News #Ocugen #files #Covaxin #IND #application #USFDA #seeks #nod #Phase3 #trial #India #News #Times #India HYDERABAD: Ocugen Inc, Bharat Biotech’s US and Canada partner for indigenously developed Covid-19 vaccine Covaxin, has submitted an

India , United-states , Hyderabad , Andhra-pradesh , Canada , Bharat , American , Shankar-musunuri , Ocugen-inc , Drug-administration , India-news , Rashtra-news

How a 12th fail teen turned Hyderabad's richest bizman | Hyderabad News

Dr Murali Krishna Prasad Divi's resilience and strategic decisions have propelled Divi’s Labs to global success as a top API manufacturer. The company

Nalgonda , Andhra-pradesh , India , Machilipatnam , Hindustan , India-general- , Hyderabad , Visakhapatnam , Murali-krishna-prasad , Divi-lab , Indian-drugs-pharmaceuticals-ltd , Us-food-drug-administration

Aurobindo to resume production at aseptic lines of Eugia Pharma's Unit-III

India Business News: Aurobindo Pharma plans to resume commercial production at Eugia Pharma's Pashamylaram formulations facility in Hyderabad. Distribution of aseptic prod

Tirupati , Andhra-pradesh , India , Hyderabad , Aurobindo-pharma , Eugia-pharma-pashamylaram , Tenofovir-disoproxil-fumarate , World-health-organisation , Eugia-pharma-specialities-ltd , Healthcare-ltd , Us-food-drug-administration , Eugia-pharma-specialities

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain in heart patients

Zydus Lifesciences Ltd announced on Friday that it has attained final approval from the US health regulatory authority to produce and distribute its generic Isosorbide Mononitrate extended-release tablets. These tablets are utilized for preventing chest pain in patients with specific heart conditions.

New-delhi , Delhi , India , Ahmedabad , Gujarat , Isosorbide-mononitrate , Zydus-lifesciences , Drug-administration , Zydus-lifesciences-ltd-on , Zydus-lifesciences-ltd , Isosorbide-mononitrate-extended-release , Generic-drug

Ganirelix Acetate: Lupin launches Ganirelix Acetate injection in US

Lupin Ltd has launched the Ganirelix Acetate injection, a single-dose prefilled syringe approved by the US FDA, for women undergoing fertility treatments. The injection, a generic equivalent to Organon USA LLC, is used to inhibit premature Luteinizing Hormone surges. It has an estimated annual sales of USD 87 million in the US.

Business-news , Breaking-newsbudget , Latest-news-updates , Economic-times , Economic-times-news-app , Daily-market-updates , Live-business , Ganirelix-acetate , Lupin , Ganirelix-acetate-injection , Usfda

RBI crackdown is the US FDA moment for financials, impacts investor sentiment

RBI’s curbs on Paytm and earlier action against Bajaj Finance will hit the sentiment towards the banking sector just like FDA actions affected the pharma segment, Alchemy Capital CIO Hiren Ved has said

India , Rakesh-jhunjhunwala , Drug-administration , Paytm-payments-bank , Paytm-payment-bank , Reserve-bank , Paytm-payment , Alchemy-capital-hiren-ved , Big-bull , Bajaj-finance , Usfda , Aytm

USFDA grants VAI classification to Dr Reddy's R&D centre

Dr Reddy's Laboratories announced that its Hyderabad-based R&D centre has received Voluntary Action Indicated (VAI) classification from the US FDA after an inspection. This classification indicates that objectionable conditions or practices were found, but no further administrative or regulatory action is required.

Hyderabad , Andhra-pradesh , India , Drug-administration , Product-development-organisation-in-bachupally , Voluntary-action-indicated , Good-manufacturing-practice , Usfda , Dr-reddys-laboratories , R-ampd-centre , Us-health-regulator

Aurobindo Pharma: Aurobindo Pharma may take a $20-million hit this quarter

The company said it is planning to resume manufacturing operations in a phased manner starting with non-aseptic lines. The US regulatory agency issued Form 483 with 9 observations against the facility at the conclusion of the inspection on February 2. The company, as an "abundant caution", put on hold manufacturing at certain lines.

Mumbai , Maharashtra , India , Visakhapatnam , Andhra-pradesh , Telangana , Aurobindo-pharma , Santhanam-subramanian , Us-drug-regulatory-agency , Eugia , Usfda

Cipla news: Cipla eyes acquisitions, inorganic partnerships in US market

Cipla plans acquisitions and inorganic partnerships in the US market while strengthening its presence in the domestic market. The company aims to improve top line growth in Europe and expand margins in South Africa. It will focus on commercial execution, resolving USFDA observations, and growing private and select tender business. Derisking top launches and resolving regulatory issues at manufacturing plants are top priorities.

Indore , Madhya-pradesh , India , South-africa , United-states , Mumbai , Maharashtra , South-african , America , Ashish-adukia , Umang-vohra , Cipla

Strides Pharma Science Singapore arm gets USFDA okay for fibromyalgia drug Pregabalin

Bangalore: Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Pregabalin capsules, 25...

Singapore , Puducherry , Pondicherry , India , Bangalore , Karnataka , Strides-pharma-science , United-states-food-drug-administration , Strides-pharma-science-limited , Strides-pharma-global , United-states