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LUPIN FDA
Lupin gets USFDA tentative approval for prostate cancer treatment drugIndian pharmaceutical giant Lupin Ltd has secured tentative approval from the US FDA for its generic enzalutamide tablets, a crucial treatm...- Biosimilars and innovation will drive Indian pharma's next growth phase: Vishal ManchandaIndia's pharmaceutical sector is pivoting beyond generics, with companies aggressively pursuing growth in biosimilars, nutraceuticals, and ...
- USFDA issues Form-483 with two observations for Lupin's Nagpur plantLupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C...
- Lupin gets warning letter from FDA for Tarapur facility, stock falls over 2%“We wish to inform you that the company has received a warning letter from the US FDA for the company’s Tarapur, Maharashtra facility. The ...
- 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...
- 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...
- Lupin gets EIR from USFDA for Pithampur facility unitLupin's Pithampur facility manufactures dermatological products, dry product inhalers, and metered dose inhalers.
- 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.
- 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...
- 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.
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- India should be proud of pharma companies like Dr. Reddy and Lupin: Jagdish Malkani, NSE & BSEJagdish Malkani, Member NSE & BSE, shares his views on pharma space.
- 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...
- 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...
- 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...
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