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USFDA AUROBINDO PHARMA
India bans 16 fixed-dose drug combinations over safety concernsIn a significant public health initiative, the ban on 16 fixed-dose drug combinations, including various antibiotics and topical formulatio...- 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, Glenmark, FDC recall products in US market over manufacturing issues: USFDAThe New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I 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...
- 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...
- Aurobindo Pharma gets USFDA nod for generic antidepressant tabletsThe company has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine tablets i...
- 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 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 USFDA final nod for generic anti-epileptic drugAurobindo Pharma has received final nod from the US health regulator to make and market generic anti-epileptic Phenytoin Sodium capsules in...
- 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 gets USFDA nod for Modafinil tablets"The company has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Modafinil tablets USP 100mg and...
- 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...
- Aurobindo gets FDA nod for CyclobenzaprineDrug firm Aurobindo Pharma has received US Food and Drug Administration (USFDA) approval for marketing Cyclobenzaprine hydrochloride tablet...
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