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AUROBINDO PHARMA. USFDA
Zaynich's blockbuster potential lifts Wockhardt's long-term outlookWockhardt's novel antibiotic, Zaynich, has received USFDA approval after a 12-year effort, sparking hopes for a turnaround after years of n...- Pharma Q4 outlook mixed: Hospitals steady, generics face revlimid dragIndian pharma and healthcare firms face a mixed March quarter. While hospitals anticipate steady growth, generic drugmakers grapple with lo...
- USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma armAurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's R...
- Aurobindo Pharma's Eugia Unit-3 gets warning letter from USFDA, shares fallAurobindo Pharma's subsidiary Eugia Pharma Specialities received a warning letter from the USFDA concerning its formulations manufacturing ...
- Aurobindo units recall products in US market for manufacturing issuesThe affected lot of the medication, which is used to treat high blood pressure, has been manufactured in India and marketed in the US marke...
- Aurobindo Pharma receives warning from SEBI for non-disclosures related to USFDA auditThe market regulator, in its letter to Aurobindo Pharma dated June 24, said the company had disclosed very limited and restricted informati...
- Sun Pharma, Aurobindo slide up to 2% as firms recall products in US marketAurobindo’s scrip fell to a low of Rs 612.60, 2 per cent lower than previous close on the National Stock Exchange, while Sun Pharma’s count...
- Aurobindo, Sun Pharma recall products in US marketAccording to the latest enforcement report issued by the US Food and Drug Administration (USFDA), the US-based arm of Aurobindo Pharma is r...
- Aurobindo Pharma gets VAI classification from USFDA for Hyderabad unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory actionAccording to USFDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicat...
- Aurobindo Pharma gets USFDA nod for anaesthesia drugQuoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 11 million for the 12 months ending Sept...
- Aurobindo Pharma gets approval to manufacture pain reliever Ibuprofen"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Ibuprofen capsules OTC, 200 mg," P...
- Aurobindo Pharma gets USFDA nod for anti-HIV drugAurobindo Pharma has received tentative approval from the USFDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, use...
- Aurobindo Pharma gets final USFDA nod for cholesterol drug"The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 m...
- Aurobindo Pharma gets final USFDA nod for osteoporosis drugDrug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Ibandronate Sodium tablets, in the American mar...
- Aurobindo Pharma gets USFDA nod for generic of Pfizer's RevatioAurobindo Pharma received approval from the USFDA to manufacture and market generic version of Pfizer's Revatio tablets used in the treatme...
- Aurobindo Pharma gets tentative nod from USFDA for Lacosamide tabletsThis ANDA is at present under litigation in the United States District Court for the District of Delaware, Aurobindo Pharma said.
- USFDA lifts import alert on Aurobindo Pharma's Hyderabad facilityUSFDA has lifted the import alert for non-sterile products manufactured at Unit-VI cephalosporin facility based in Hyderabad.
- Aurobindo Pharma receives warning letter from USFDA; stock over 9 pc downAurobindo Pharma said it has received a warning letter from the USFDA with regard to its antibiotics manufacturing unit in Hyderabad.
- Aurobindo Pharma receives warning letter from USFDAAurobindo Pharma today said it has received a warning letter from the US health regulator with regard to its antibiotics manufacturing unit...
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