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ANDA APPROVALS
Concord Biotech shares gain 6% after USFDA approval for Tofacitinib tabletsConcord Biotech's shares surged over 6% after receiving USFDA approval for its Tofacitinib Tablets in 5 mg and 10 mg strengths. This approv...- Concord Biotech shares jump 8% on USFDA nod for Mycophenolate Mofetil oral suspensionConcord Biotech shares saw a significant jump on Wednesday. This surge followed the company's announcement of receiving approval from the U...
- Alembic gets USFDA nod for generic levothyroxine sodium tabletsAlembic Pharmaceuticals has secured final approval from the US health regulator for its generic levothyroxine sodium tablets. This medicati...
- Alembic Pharma gets USFDA tentative nod for generic prostate cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic version of Darolutamide tablets, targeting prostate c...
- Cipla gets USFDA nod for generic respiratory issues treatment inhalation aerosolPharma major Cipla has secured final approval from the US health regulator for its generic albuterol sulfate inhalation aerosol. This marks...
- Alembic Pharma gets USFDA nod for generic cancer, arthritis injectionAlembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic methotrexate injection, used t...
- Marksans Pharma gets USFDA nod for generic Benzonatate capsulesMarksans Pharma has received final approval from the US Food and Drug Administration for its generic version of Benzonatate capsules used t...
- Alembic Pharma gets USFDA nod for generic high blood pressure treatment drugAlembic Pharmaceuticals announced that it has secured final approval from the USFDA for its generic amlodipine and atorvastatin tablets, us...
- Alembic Pharma gets USFDA nod for generic drug used to treat schizophreniaAlembic Pharmaceuticals has received final approval from the USFDA for its generic version of Paliperidone extended-release tablets, used t...
- Alembic Pharma gets USFDA nod for bipolar disorder treatment drugIn a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration (USFDA) for its abbr...
- Alembic Pharma JV gets USFDA nod for antifungal topical solutionAleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application ...
- Alembic Pharmaceuticals gets USFDA's tentative approval for type 2 diabetes drugThe tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Glyxamb...
- Granules India gets USFDA nod for overactive bladder treatment capsule"The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application filed by Granules Pharmaceuticals, Inc, a wh...
- Aurobindo Pharma climbs 4% as JPM initiates coverage with overweight ratingThe brokerage has a target price of Rs 900, which at Tuesday’s closing of Rs 759.30 on BSE suggested an 18 per cent upside potential for th...
- 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 ...
- Claris Lifesciences surges on ANDA approvalStocks of Claris Lifesciences climbed over 4% after one of its existing shareholders sold out its entire stake in the company via a block d...
- Jubilant Life gets USFDA nod for generic anti-asthma tablets"This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, we have received 10 ANDA ...
- Indian pharmaceutical companies bag 40 per cent of ANDAs approved by USFDA: ReportIndian pharma companies bagged around 40% of all Abbreviated New Drug Approvals (ANDA) approvals from USFDA between January and July 2013.
- Claris Lifesciences to resume export to US post USFDA nodThe approval will allow Claris to manufacture and sell its products in te US and also receive abbreviated new drug application approvals, t...
- Glenmark subsidiary gets 3 ANDA approvals, stock upGlenmark Generics Inc, a subsidiary of Glenmark Pharmaceuticals, has received three ANDA approvals by the USFDA for Indomethacin 25mg and 5...
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