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LUPIN US FDA
US FDA issues warning letter to Lupin's Tarapur unitThe United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin's Tarapur, Maharashtra facility, the company s...29 Sep, 2022, 10.39 AM IST- USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated'According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanction...13 Jan, 2020, 10.40 AM IST
- Lupin gets EIR from USFDA for Pithampur facility unitLupin's Pithampur facility manufactures dermatological products, dry product inhalers, and metered dose inhalers.10 Dec, 2018, 03.51 PM IST
- Lupin gets EIR from USFDA for Pithampur facilityIn November last, Lupin had received warning letter from USFDA (US Food and Drug Administration) for its manufacturing facilities in Goa an...06 Apr, 2018, 11.42 AM IST
- Lupin receives US FDA approval for anti-inflammatory topical solutionFluocinonide topical solution USP, 0.05% clocked sales of $32.4 million in the US, Lupin said in a release citing IMS MAT March 2017 data.24 Jul, 2017, 03.45 PM IST
- Lupin rallies on USFDA approval for generic drugAt 09:40 am, Lupin shares were trading 1.06 per cent higher at 1,533. They hit a low of Rs 1,526 and a high of Rs 1,545 in the first 30 min...30 Nov, 2016, 10.52 AM IST
- Lupin receives USFDA approval for generic drug to treat sleep disordersLupin's share prices rose 0.82% on Tuesday to close at Rs1,517.05 on BSE, where the benchmark Sensex ended 0.17% higher.30 Nov, 2016, 01.29 AM IST
- Committed to close corrective action at Goa by December: LupinIt said that even if the US Food and Drug Administration decides to hold back approvals from the Goa facility it won't have much impact on ...13 Jun, 2016, 04.22 PM IST
- Lupin shares pull back as co clarifies on US FDA action at MandideepLupin’s clarifications — the second in two days — countered issues raised by IIFL Capital, which had termed the observations as "very serio...31 Mar, 2016, 03.51 AM IST
- Lupin shares fall may be overdone as review minorBut a closer reading of the FDA observations show that they could be of a minor nature and may not lead to any significant impact on earnin...16 Mar, 2016, 02.10 AM IST
- Lupin gets FDA approval for generic Femhrt tabletsThe company has received received the final approval from the United States Food and Drug Administration to market Fyavolv tablets, it said.28 Dec, 2015, 04.15 PM IST
- Lupin recalls Quinapril tablets from US marketLupin has said its US subsidiary Lupin Pharmaceuticals Inc initiated voluntary recall of multiple lots of Quinapril Tablets USP from US mkt...29 Jan, 2014, 05.09 PM IST
- Several Indian companies get FDA nod for anti-depressant drugThe US Food and Drug Administration has approved the first generic versions of Cymbalta, a prescription medicine used in treatment of depre...12 Dec, 2013, 04.00 PM IST
- Lupin gets USFDA nod for lamotrigine tabletsLupin Ltd said its unit has received US FDA approval for lamotrigine in tablets form.04 Jun, 2010, 11.13 AM IST
- US FDA inspects Lupin's new plant in IndoreThe US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...30 Nov, 2009, 01.06 AM IST
- Lupin sends notice to Oscient over cholesterol genericIndian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory appro...05 Dec, 2008, 12.08 AM IST
- Lupin’s MP plant under USFDA scannerThe US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...14 Nov, 2008, 12.00 AM IST
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