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LUPIN USFDA
Lupin gets tentative nod from USFDA for generic Sugammadex injectionLupin Ltd, a prominent name in the pharmaceutical world, revealed on Tuesday that it has gained tentative approval from the US health autho...31 Mar, 2026, 12.15 PM IST- Lupin gains on USFDA nod to market Sevelamer CarbonateAccording to data for September 2021 released by IQVIA MAT September, Sevelamer Carbonate for oral suspension had estimated annual sales of...27 Dec, 2021, 10.31 AM IST
- Lupin gets warning letter from USFDA for Somerset facilityThe United States Food and Drug Administration (USFDA) had inspected the company's Somerset, New Jersey, facility from September 10, 2020, ...13 Jun, 2021, 04.40 PM IST
- Lupin gets 2 observations from USFDA for Nagpur facility"The inspection closed with two 483 observations," Lupin said.11 Jan, 2020, 03.41 PM IST
- Sell Lupin, target Rs 800: Elara CapitalSell Lupin at a price target of Rs 800.25 Apr, 2019, 05.25 PM IST
- Lupin shares fall 3% as USFDA warns of regulatory actionUSFDA warned the firm that it may withhold approval of any pending applications or supplements in which this facility is listed.24 Apr, 2019, 03.43 PM IST
- Lupin's Pithampur unit gets inspection closure report from USFDAPithampur Unit-3 facility is involved in the manufacture of metered dose inhalers.02 Apr, 2019, 03.46 PM IST
- Lupin recalls over 23,000 bottles of antibiotic drug in USDrug major Lupin is recalling over 23,000 bottles of an antibiotic drug in the US for being sub-potent, US Food and Drug Administration (US...09 Jan, 2019, 02.30 PM IST
- Lupin gets EIR from USFDA for its Nagpur facilityUSFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.12 Nov, 2018, 12.00 PM IST
- USFDA issues warning letter to Lupin's Goa, Indore plantsOn Lupin's Pithampur (Indore) plant, the US health regulator said the company invalidated initial OOS laboratory results without adequate i...16 Nov, 2017, 11.43 PM IST
- Lupin gets warning letter from USFDA for Goa, Indore unitsThe company upholds quality and compliance issues with utmost seriousness and remains fully committed to be compliant with cGMP quality sta...07 Nov, 2017, 02.19 PM IST
- Lupin's Aurangabad plant undergoes USFDA inspectionLast week, Unit 1 of Lupin's Pithampur facility had successfully undergone inspection on good manufacturing practice (GMP) as well as PAI b...31 Jul, 2017, 03.09 PM IST
- Lupin recalls 12,480 bottles of anti-depressant drug from USLupin Pharmaceuticals Inc is recalling 12,480 bottles of Paroxetine extended-release tablets in the strength of 12.5 mg manufactured by Lup...19 Jul, 2017, 03.54 PM IST
- USFDA makes 8 observations after Lupin's Aurangabad unit visitThe facility was recently inspected by the United States Food and Drug Administration. The inspection was completed on April 26, 2017, Lupi...09 May, 2017, 05.41 PM IST
- Lupin gets USFDA nod for Diclofenac capsules' generic versionLupin has 139 product filings pending approval with the USFDA. Cumulative filings with the USFDA now stand at 341 with the company having r...06 Dec, 2016, 01.43 PM IST
- Sharekhan puts buy on LupinSharekhan has come out with a ‘buy’ on Lupin on account of its differentiated business model with global dominance in certain products, foc...24 Dec, 2008, 02.00 AM IST
- Lupin gets US nod for CefdinirLupin Ltd on Friday said it has received the approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Cefdinir Suspensio...02 Jun, 2006, 03.50 PM IST
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