https://www.livemint.com/topic/usfda
Usfda: Latest Usfda News, Photos, Videos and Podcasts | Mint
Usfda: Get the latest Usfda news, photos, videos, and podcasts. Explore more for Usfda breaking news, opinions, special reports, and more on mint.
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https://www.business-standard.com/amp/markets/capital-market-news/alembic-pharma-gains-after-receiving-usfda-nod-for-betamethasone-valerate-foam-124082600526_1.html
Alembic Pharma gains after receiving USFDA nod for Betamethasone Valerate Foam | Capital Market...
https://www.business-standard.com/amp/industry/news/sun-pharma-zydus-recall-medicines-in-us-over-quality-concerns-usfda-125031600461_1.html
Sun Pharma, Zydus recall medicines in US over quality concerns: USFDA | Industry News - Business...
Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration...
https://www.business-standard.com/amp/markets/capital-market-news/shalby-gains-on-usfda-clearance-for-knee-replacement-device-125011600379_1.html
Shalby gains on USFDA clearance for knee replacement device | Capital Market News - Business...
Shalby rallied 3.50% to Rs 230.60 after its step down subsidiary, Shalby Advanced Technologies (SAT) Inc., USA, received U.S. Food and Drug Administration...
https://www.business-standard.com/article/companies/alembic-arm-receives-final-usfda-approval-for-generic-fever-blisters-drug-122050400324_1.html
Alembic arm receives final USFDA approval for generic fever blisters drug | Company News - Business...
Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic...
https://www.business-standard.com/article/companies/zydus-cadila-gets-usfda-nod-to-market-mineral-supplement-tablets-120091800444_1.html
Zydus Cadila gets USFDA nod to market mineral supplement tablets | Company News - Business Standard
Zydus Cadila said it has received approval from USFDA to market potassium chloride extended release tablets, a mineral supplement used to treat or prevent low...
https://www.financialexpress.com/about/usfda/?ref=articlehyperlinking
Usfda News: Usfda Latest News, Usfda Today news, Usfda Breaking News | The Financial Express
Usfda News: Check here latest news and updates about Usfda in India. Read top headlines and breaking news today in India about Usfda on financialexpress.com.
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https://www.business-standard.com/pti-stories/national/usfda-pulls-up-intas-pharma-for-manufacturing-lapses-at-ahmedabad-plant-123121000199_1.html
USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant | Company News - Business...
The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP)...
https://www.ndtvprofit.com/business/zydus-lifesciences-gujarat-plant-receives-official-action-indicated-notice-from-usfda-9985355
Zydus Lifesciences' Gujarat Plant Receives USFDA 'Official Action Indicated' Notice
The USFDA has determined that the inspection classification of the injectables manufacturing facility in Gujarat is 'Official Action Indicated'.
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https://www.business-standard.com/amp/markets/news/indoco-remedies-shares-rise-over-3-on-usfda-nod-for-allergy-drug-124100400462_1.html
Indoco Remedies shares rise over 3% on USFDA nod for allergy drug | News on Markets - Business...
Mumbai based pharmaceutical company Indoco Remedies share price surged 3.13 per cent at Rs 349.95 per share on the BSE
https://www.businesstoday.in/markets/company-stock/story/gland-pharma-shares-rise-usfda-inspection-pashamylaram-facility-407009-2023-11-24
Gland Pharma shares rise 6% after USFDA closes inspection of Hyderabad facility Pointers -...
Nov 24, 2023 - Gland Pharma shares hit an intraday high of Rs 1817.5, rising 6.37% against the previous close of Rs 1708.30 on BSE.
https://www.business-standard.com/markets/capital-market-news/glenmark-receives-usfda-approval-for-acetaminophen-and-ibuprofen-tablets-250-mg-125-mg-otc-124042900365_1.html
Glenmark receives USFDA approval for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) |...
https://www.financialexpress.com/business/healthcare-lupin-gets-tentative-approval-from-usfda-for-generic-cancer-tablets-2648422/
Lupin gets tentative approval from USFDA for generic cancer drug - Healthcare News | The Financial...
The tablets are prescribed to treat certain types of cancer and it works by slowing or stopping the growth of cancer cells.
https://www.business-standard.com/markets/capital-market-news/alembic-pharmaceuticals-receives-usfda-approval-for-betamethasone-valerate-foam-124082400417_1.html
Alembic Pharmaceuticals receives USFDA approval for Betamethasone Valerate Foam | Capital Market...
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https://www.business-standard.com/amp/markets/capital-market-news/zydus-lifesciences-receives-usfda-tentative-approval-for-diroximel-fumarate-delayed-release-capsules-124071000698_1.html
Zydus Lifesciences receives USFDA tentative approval for Diroximel Fumarate Delayed-Release...
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Diroximel Fumarate Delayed-Release...
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https://www.biospace.com/lorenz-docubridge-evalidator-and-automator-go-live-at-the-usfda
LORENZ docuBridge, eValidator, and Automator go live at the USFDA - BioSpace
Nov 3, 2020 - The U.S. Food and Drug Administration is now using LORENZ docuBridge and eValidator. The Center for Drug Evaluation and Research and the Center for Biologics...
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https://www.business-standard.com/amp/markets/capital-market-news/emcure-pharma-s-maharashtra-facility-gets-2-usfda-observations-125022600385_1.html
Emcure Pharma's Maharashtra facility gets 2 USFDA observations | Capital Market News - Business...
Emcure Pharmaceuticals has announced that the United States Food and Drug Administration (USFDA) had conducted a current Good Manufacturing Practices (cGMP)...
https://www.business-standard.com/amp/markets/capital-market-news/cipla-jumps-on-receiving-approval-from-usfda-for-protein-bound-paclitaxel-125041100280_1.html
Cipla jumps on receiving approval from USFDA for protein-bound Paclitaxel | Capital Market News -...
Cipla rallied 3.80% to Rs 1,470.15 after the firm received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug...
https://menafn.com/1111063411/Alkem-Labs-Gets-7-USFDA-Observations-At-Daman-Plant-After-Inspection
Alkem Labs Gets 7 USFDA Observations At Daman Plant After Inspection
Alkem Labs Gets 7 USFDA Observations At Daman Plant After Inspection. New Delhi, May 3 (IANS) Pharmaceutical major Alkem Laboratories has come under regulatory...
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https://www.businesstoday.in/markets/company-stock/story/lupin-shares-fall-4-after-usfda-issues-form-483-for-pithampur-plant-375505-2023-03-31
Lupin shares fall 4% after USFDA issues Form 483 for Pithampur plant - BusinessToday
Mar 31, 2023 - Lupin shares plunged 3.18% to Rs 106.50 against the previous close of Rs 110 on BSE. Market cap of the firm fell to Rs 10,970 crore
https://www.outlookindia.com/healthcare-spotlight/alembic-pharma-gets-usfda-approval-for-ticagrelor-tablets-60-mg
Alembic Pharma Gets USFDA Approval For Ticagrelor Tablets, 60 mg | Outlook India
Alembic Pharma got USFDA approval for Ticagrelor Tablets 60 mg, a generic of Brilinta. Used to reduce CV death, MI, and stroke risks, it has a USD 236 M...
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https://www.business-standard.com/companies/news/lupin-secures-a-tentative-usfda-approval-for-rivaroxaban-tablets-124012300832_1.html
Lupin secures a tentative USFDA approval for Rivaroxaban tablets | Company News - Business Standard
Lupin boasts 15 manufacturing sites, 7 research centres, and a global team of more than 20,000 professionals
https://www.business-standard.com/amp/markets/capital-market-news/alembic-pharmaceuticals-receives-usfda-approval-for-carbamazepine-tablets-125041700412_1.html
Alembic Pharmaceuticals receives USFDA approval for Carbamazepine Tablets | Capital Market News -...
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https://www.business-standard.com/markets/capital-market-news/suven-pharma-hyderabad-facilities-clear-usfda-inspection-124022600309_1.html
Suven Pharma Hyderabad facilities clear USFDA inspection | Capital Market News - Business Standard
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https://www.business-standard.com/amp/companies/news/zydus-lifesciences-unit-gets-10-observations-from-usfda-after-inspection-124042400362_1.html
Zydus Lifesciences unit gets 10 observations from USFDA after inspection | Company News - Business...
Zydus Lifesciences on Wednesday said the US health regulator has issued ten observations after inspecting its injectable manufacturing plant near Vadodara in...
https://www.business-standard.com/amp/markets/news/biocon-shares-gain-4-after-usfda-gives-vai-tag-to-its-malaysia-unit-125011300141_1.html
Biocon shares gain 4% after USFDA gives VAI tag to its Malaysia unit | News on Markets - Business...
Shares of Biocon were in high demand on Monday after the pharmaceutical company's subsidiary Biocon Biologics' Johor Bahru facility in Malaysia was classified...
https://www.business-standard.com/amp/content/press-releases-ani/rusan-pharma-s-api-plant-in-ankleshwar-receives-india-usfda-gmp-approval-124072200442_1.html
Rusan Pharma's API Plant in Ankleshwar Receives (India) USFDA GMP Approval
Ankleshwar (Gujarat) [India], July 22: RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of addiction treatment...
https://www.business-standard.com/article/companies/zydus-lifesciences-gets-usfda-nod-for-generic-valbenazine-roflumilast-122101700475_1.html
Zydus Lifesciences gets USFDA nod for generic Valbenazine, Roflumilast | Company News - Business...
Zydus Lifesciences on Monday said it has got tentative approval from the US health regulator to market its generic versions of Valbenazine capsules and...
zydus lifesciences
https://www.business-standard.com/amp/markets/capital-market-news/cipla-receives-usfda-approval-for-protein-bound-paclitaxel-for-injectable-suspension-125041100207_1.html
Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension | Capital...
Cipla's Protein-bound Paclitaxel is an AB-rated generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for Injectable Suspension 100...
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https://www.freepressjournal.in/business/biocon-biologics-viatris-get-usfda-nod-for-first-interchangeable-biosimilar-insulin-product
Biocon Biologics, Viatris get USFDA nod for first interchangeable biosimilar insulin product
Biocon Biologics, Viatris get USFDA nod for first interchangeable biosimilar insulin product
biocon biologics
https://www.marketscreener.com/news/zydus-lifesciences-receives-final-usfda-approval-for-dapagliflozin-tablets-ce7e50dada8ef625
Zydus Lifesciences receives final USFDA approval for dapagliflozin tablets | MarketScreener
Apr 8, 2026 - Zydus Lifesciences Ltd: Receives final USFDA approval for dapagliflozin tablets ...
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https://menafn.com/1110999774/USFDA-Issues-Form-483-With-Three-Observations-To-Lupin-US-Facility
USFDA Issues 'Form 483' With Three Observations To Lupin US Facility
USFDA Issues 'Form 483' With Three Observations To Lupin US Facility. New Delhi, April 18 (IANS) Major drug maker Lupin on Saturday said that the US health...
form 483usfdaissues
https://www.newindianexpress.com/business/2018/sep/15/sun-pharma-and-sparcs-xelpros-gets-usfda-nod-1872327.html
Sun Pharma and SPARC's XELPROS gets USFDA nod
XELPROS will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd's wholly-owned subsidiary.
sun pharmasparcxelprosgetsusfda
https://www.financialexpress.com/business/news/generic-ozempic-semaglutide-gets-tentative-usfda-approval-onesource-is-cdmo-partner/4214452/
Generic Ozempic semaglutide gets tentative USFDA approval; OneSource is CDMO partner - Business...
OneSource Specialty Pharma says partner Orbicular secures USFDA tentative approval for generic Ozempic semaglutide injection, boosting CDMO capabilities.
generic ozempic
https://www.business-standard.com/article/companies/usfda-approves-production-of-biocon-biosimilar-at-new-bengaluru-unit-119112701273_1.html
USFDA approves production of Biocon biosimilar at new Bengaluru unit | Company News - Business...
The US Food and Drug Administration's (USFDA's) nod to Biocon's supplemental biologics licence application for the new unit will expand the company's capacity...
https://www.deccanherald.com/business/companies/official-action-indicated-for-biocon-arms-unit-in-malaysia-after-usfda-inspection-2731563
Official action indicated for Biocon arm's unit in Malaysia after USFDA inspection
The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in...
https://www.business-standard.com/amp/companies/news/zydus-life-gets-usfda-approval-to-market-heart-failure-treatment-drug-124071000661_1.html
Zydus Life gets USFDA approval to market heart failure treatment drug | Company News - Business...
Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets...
https://www.business-standard.com/amp/markets/capital-market-news/usfda-conducts-surprise-inspection-of-gland-pharma-s-dundigal-facility-124072500625_1.html
USFDA conducts surprise inspection of Gland Pharma's Dundigal facility | Capital Market News -...
The inspection was concluded with TWO (2) 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these...
https://www.devdiscourse.com/article/health/3875905-alembic-pharmaceuticals-secures-usfda-approval-for-methotrexate-injection
Alembic Pharmaceuticals Secures USFDA Approval for Methotrexate Injection | Health
Alembic Pharmaceuticals Ltd has received final USFDA approval for its methotrexate injection, used to treat various cancers and arthritis. The approval covers...
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https://www.business-standard.com/amp/markets/capital-market-news/alembic-pharma-gets-usfda-nod-for-seizure-treatment-drug-124122000599_1.html
Alembic Pharma gets USFDA nod for seizure treatment drug | Capital Market News - Business Standard
https://www.business-standard.com/india-news/indian-pharma-sites-outpace-global-standards-in-usfda-inspections-for-2023-124062700386_1.html
Indian pharma sites outpace global standards in USFDA inspections for 2023 | India News - Business...
Indian Pharma Companies: The USFDA categorised 13 per cent (19 out of 145 inspections) of Indian facilities as 'Official Action Indication'(OAI), which is...
https://tagrix.net/
Osimertinib - USFDA Approved Latest Drug for Lung Cancer Patients
Jan 8, 2026 - Osimertinib USFDA Approved Latest Drug for Lung Cancer Patients
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https://www.business-standard.com/amp/markets/capital-market-news/lupin-gets-eir-from-usfda-for-nagpur-facility-125041700671_1.html
Lupin gets EIR from USFDA for Nagpur facility | Capital Market News - Business Standard
Lupin announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for drug-medical device...
https://www.ndtvprofit.com/business/biocon-facility-gets-inspection-report-from-usfda-voluntary-action-indicated-9989091
Biocon Facility Gets Inspection Report From USFDA, Voluntary Action Indicated
This was based on a Good Manufacturing Practice inspection conducted by the agency between June 17 and 21.
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https://www.business-standard.com/amp/markets/capital-market-news/zydus-life-gets-usfda-nod-for-deflazacort-tablets-to-treat-duchenne-muscular-dystrophy-125041200212_1.html
Zydus Life gets USFDA nod for Deflazacort tablets to treat Duchenne muscular dystrophy | Capital...
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (USFDA) to manufacture Jaythari (Deflazacort) tablets in four strengths...
https://www.republicworld.com/business/torrent-pharma-share-price-surges-nearly-2-after-this-usfda-update
Torrent Pharma Share Price Surges Nearly 2% After This USFDA Update | Republic World
Apr 13, 2026 - The shares of Torrent Pharma surged nearly 2% to hit an intra-day high of Rs 4210 apiece on Monday, April 13 after the USFDA inspection of its Bileshwarpura...
https://www.business-standard.com/article/companies/usfda-issues-warning-letter-to-glenmark-pharma-for-lapses-at-goa-plant-122121100277_1.html
USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant | Company News - Business...
The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control...
https://www.business-standard.com/markets/capital-market-news/alkem-labs-slips-after-baddi-facility-gets-10-observations-from-usfda-124032800243_1.html
Alkem Labs slips after Baddi facility gets 10 observations from USFDA | Capital Market News -...
Alkem Laboratories declined 2.05% to Rs 4,874.25 after the US Food and Drug Administration (USFDA) conducted GMP and Pre-approval inspection at its...
https://www.business-standard.com/amp/markets/news/biocon-share-jumps-6-on-usfda-s-vai-tag-to-bengaluru-facility-details-124111100295_1.html
Biocon share jumps 6% on USFDA's 'VAI' tag to Bengaluru facility; details | News on Markets -...
The surge in Biocon share price came after the company announced that United States Food and Drug Administration (USFDA) has classified Biocon Biologics'...
https://www.business-standard.com/article/companies/regrow-s-cell-therapy-product-gets-orphan-drug-status-from-usfda-119012000684_1.html
Regrow's cell therapy product gets orphan drug status from USFDA | Company News - Business Standard
Start-up in talks with MNCsto out-license Ossgrow for developed markets
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USFDA Cleared, Best Non-Surgical Way for Hair Growth - Beautiful Hair and Skin with LLLT - the...
Dec 3, 2022 - Hair Growth - the Non-Surgical Way, with the most credible, USFDA Cleared, iGrow Laser Hair-Growth Helmet, Home-Use DeviceBeautiful Hair and Skin with LLLT -...
https://www.business-standard.com/article/pti-stories/alembic-pharma-receives-4-observations-from-usfda-for-panelav-facility-120031600338_1.html
Alembic Pharma receives 4 observations from USFDA for Panelav facility
Alembic Pharmaceuticals on Monday said that US health regulator has conducted an inspection at it Panelav facility in Gujarat and issued Form 483 with four...
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https://www.business-standard.com/amp/markets/capital-market-news/alembic-pharma-s-gujarat-facility-gets-4-observations-from-usfda-124030900071_1.html
Alembic Pharma's Gujarat facility gets 4 observations from USFDA | Capital Market News - Business...
Alembic Pharmaceutical said that USFDA had conducted inspection at its oncology (injectable and oral solid) formulation facility (F-2) at Panelav,Gujarat.
https://globalcalcium.com/
Global Calcium Private Limited | Global Calcium is USFDA, EU-GMP, COFEPRIS approved manufacturer...
Global Calcium is USFDA, EU-GMP, COFEPRIS approved manufacturer specialized in Active Pharmaceutical Ingredients and Mineral Actives.
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