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#JustIn | #ZydusLife gets tentative #USFDA nod for #Ibrutinib tablets

Alert: Ibrutinib is used to treat adult patients with chronic Lymphocytic Leukaemia

Alert: Ibrutinib tablets had annual sales of $2,148.9 m in the US
#JustIn | #ZydusLife receives final approval from #USFDA for #DiltiazemHydrochlorideTablets

Alert: Diltiazem Hydrochloride is used to treat high blood pressure & to control angina (chest pain)
#USFDA wraps Aurobindo Pharma’s Bachupally plant inspection with 8 observations
#NewsFlash | #Lupin receives approval from #USFDA for Lenalidomide capsules

πŸ‘‰Lenalidomide is used in the treatment of multiple myeloma & lepra reaction

πŸ‘‰Lenalidomide Capsules had estimated annual sales of $7,511 Million in the US
#JustIn | #AlembicPharma receives #USFDA final approval for #Paroxetine extended-release tablets.

Paroxetine tablet is used to treat treat depression, and sometimes obsessive compulsive disorder (OCD), panic attacks, anxiety or post-traumatic stress disorder (PTSD)
#JustIn | #AlembicPharma receives final approval from the #USFDA for its ANDA for Ticagrelor Tablets.

The drug is used to reduce the risk of cardiovascular death, myocardial infarction & stroke in patients with acute coronary syndrome
#JustIn | #GranulesIndia: #USFDA issues #EIR, classifies API unit-1 unit, #Hyderabad as voluntary action indicated
#ZydusLife receives EIR for SEZ II manufacturing facility, #Ahmedabad

#USFDA conducted pre-approval inspection from August 11-14, 2025

Inspection concludes with NIL observations at Zydus Life facility
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#JustIn | #Lupin’s #Aurangabad facility gets #USFDA's establishment inspection report

Alert: A product-specific pre-approval inspection was conducted from Sep 1 To Sep 5, 2025
#JustIn | #GlenmarkPharma gets #USFDA Establishment Inspection Report (#EIR) with Voluntary Action Indicated (VAI) status for its #Monroe, #NorthCarolina facility
#JustIn | #AlembicPharma gets #USFDA final approval for #DifluprednateOphthalmicEmulsion

Alert: Difluprednate Ophthalmic Emulsion is used to treat eye pain & redness
#JustIn | #NATCOPharma’s API unit in #Chennai gets Establishment Inspection Report (#EIR) from #USFDA, receives seven observation in the form-483.

Alert: US FDA conducted an inspection at the API division from November 17-21, 2025
#JustIn | #SunPharma Announces #USFDA Acceptance Of sBLA Application for #ILUMYA

⏩Alert: ILUMYA Is Used For The Treatment Of Adults With Active Psoriatic Arthritis

⏩Alert: sBLA Is Supplemental Biologics License Application
#JustIn | #AlembicPharma announces #USFDA final approval for #DapagliflozinTablets

Pdt used primarily to improve Glycemic control in adults with type 2 diabetes

Pdt has an est mkt size of $10,487 m for 12 months ending Dec 2025
#JustIn | #AurobindoPharma gets #USFDA approval for Dapagliflozin & Metformin Hydrochloride extended-release tablets

Alert: Dapagliflozin & Metformin tablets are used to aid blood sugar control in adults with type-2 diabetes
#JustIn | #ZydusLife receives final #USFDA approval for #DapagliflozinTablets

Dapagliflozin Tablets has annual sales of $10.2 Bn in the United States

Alert: Dapagliflozin Tablets is indicated for treatment of adults with type 2 Diabetes
#StocksToWatch | Here's a list of stocks in focus going into trade today

🟒#TruAltBio: Secures β‚Ή150 cr financial assistance under PM Ji-Van Yojana for SAF proj

🟒#Groww/#AngelOne: #SEBI proposes allowing NCDs for MTF funding, expand broker funding limits

🟒Aurobindo: Necessary Approval From US FTC For Acquisition Of Lannett Business Has Been Obtained Today

πŸ”΄#ITStocks: #Accenture cuts CC rev growth guidance on #WestAsia impact, earnings miss est

πŸ”΄#JubilantPharmova: #USFDA issues 8 observations for Spokane, US unit

πŸ”΄#Muthoot/#Mannapuram: Gold prices fall 1.5% overnight, below $4,200/oz
#USFDA Issues Form 483 With 1 Observation Post Inspection At #RubiconResearch Satara Mfg

⏩Inspection Took Place From October 5 To October 9