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AUROLIFE PHARMA LLC
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 subsidiary's plant gets one observation from USFDA"At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and the...
- Aurobindo Pharma drops 3% as USFDA issues 'Form 483' to US arm unitAt the end of the inspection, Aurolife has been issued a 'Form 483' with one observation and the observation is procedural in nature and th...
- Aurobindo Pharma gets USFDA nod for its expectorant tabletsThe company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture its generic Guaifenesin ...
- Aurobindo Pharma says co, subsidiary made party to litigation proceeding in USThe drug firm in a regulatory filing however said it is yet to receive a copy of the proceeding and denied what it said were 'baseless alle...
- 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 to market kidney ailment drugAurobindo Pharma has a total of 331 ANDA approvals (294 final nod, including 16 from Aurolife Pharma LLC and 37 tentative approvals) from t...
- Aurobindo Pharma gets USFDA nod for HIV drug"The company has received final approval from the USFDA to manufacture abacavir sulfate and lamivudine tablets, 600 mg/ 300 mg."
- Aurobindo Pharma gets final USFDA nod for gastro reflux drugAurobindo Pharma has received final approval from the USFDA to manufacture and market pantoprazole sodium for injections, used for the trea...
- Aurobindo Pharma gets USFDA nod for osteoporosis drug"The approved product has an estimated market size of USD 96 million for the twelve months ended January 2016 according to IMS," it said.
- Aurobindo Pharma receives USFDA nod for generic drugThe company's product is generic version of Duramed Pharmaceuticals Aygestin tablets in the same strength, Aurobindo Pharma said.
- Aurobindo gets USFDA nod to market heart disease drugAurobindo Pharma has received US health regulator's approval to market Eptifibatide Injection, used in the treatment of acute coronary synd...
- Aurobindo Pharma gets USFDA nod for oral contraceptive tabletsThe product has an estimated market size of $64 million for the twelve months ending October 2015 according to IMS, Aurobindo Pharma said.
- Aurobindo gets USFDA nod for multi disease treatment injectionAurobindo Pharma today said it has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Ph...
- Aurobindo Pharma gets USFDA nod for generic hypertension tabletsAurobindo now has a total of 211 ANDA approvals (183 final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from ...
- 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 USFDA nod for Cefadroxil oral suspensionThe product is the generic equivalent of Warner Chilcott Company Inc's Duricef for oral suspension in the same strengths.
- Aurobindo Pharma gets tentative nod from USFDA for Anti-AIDS drugAurobindo Pharma today said it has received tentative approval from the US health regulator to manufacture and market its anti-AIDS combina...
- Aurobindo Pharma gets USFDA nod for Nafcillin injectionsThe company currently has a total of 171 ANDA approvals (145 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approval...
- Aurobindo Pharmaceuticals gets USFDA nod for nausea injectionsThe injections are the generic equivalent of GlaxoSmithKline's Zofran injection, Aurobindo Pharma said.
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