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    Aurobindo Pharma Limited
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    Country
    India
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    Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
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    +91 (40) 6672 5000
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    enquiries@pharmacompass.com
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    https://www.aurobindo.com/
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    • Development Update
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    Aurobindo Pharma Receives USFDA Approval for Mometasone Furoate Monohydrate Nasal Spray 50 mcg/spray

    Details:

    Nasonex-Generic (mometasone furoate monohydrate) nasal spray is a corticosteroid. It has recently received approval from the U.S. FDA for the treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis.


    Lead Product(s): Mometasone Furoate

    Therapeutic Area: Immunology Product Name: Nasonex-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 19, 2024

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    Aurobindo Pharma receives USFDA Approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg

    Details:

    Emflaza (deflazacort) is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor as an agonist. It is approved for the treatment of duchenne muscular dystrophy in patients 5 years of age and older.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Product Name: Emflaza

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 12, 2024

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    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details:

    Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Product Name: Noxafil-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 27, 2023

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    Aurobindo Pharma Gets USFDA Nod for HIV drug

    Details:

    Darunavir tablets, generic of Prezista, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.


    Lead Product(s): Darunavir

    Therapeutic Area: Infections and Infectious Diseases Product Name: Prezista-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 29, 2023

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    Aurobindo Pharma Gets U.S. FDA nod for Generic Icatibant Injection

    Details:

    Icatibant injection, for subcutaneous is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of ageand older.


    Lead Product(s): Icatibant Acetate

    Therapeutic Area: Genetic Disease Product Name: Firazyr-Generic

    Highest Development Status: ApprovedProduct Type: Peptide

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 16, 2023

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    Eugia Pharma Receives USFDA Approval For Plerixafor Injection

    Details:

    Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.


    Lead Product(s): Plerixafor

    Therapeutic Area: Oncology Product Name: Mozobil-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2023

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    Aurobindo Pharma Arm Gets USFDA Nod for Sevelamer Hydrochloride Tablets

    Details:

    Sevelamer hydrochloride tablets of strengths 400 mg and 800 mg used to control serum phosphorus in patients with chronic kidney disese (CKD) on dialysis.


    Lead Product(s): Sevelamer Hydrochloride

    Therapeutic Area: Nephrology Product Name: Renagel-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 12, 2023

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    Eugia Pharma Receives USFDA Approval for Diltiazem Hydrochloride Injection, 25 mg/5 mL (5 mg/mL), 50 mg/10 mL (5 mg/mL), and 125 mg/25 mL (5 mg/mL), Sin...

    Details:

    Diltiazem hydrochloride inhibits the inflow of calcium ions into the cardiac muscle during depolarization. Reduced intracellular calcium concentrations increase smooth muscle relaxation, resulting in arterial vasodilation and decreased blood pressure.


    Lead Product(s): Diltiazem Hydrochloride

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: Diltiazem Hydrochloride-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 29, 2023

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    Aurobindo's Generic Ibuprofen, Pseudoephedrine Hydrochloride Receives Approval in U.S.

    Details:

    Ibuprofen and pseudoephedrine hydrochloride is a combination of NSAID and alpha-adrenergic stimulator which is used to relieve symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose.


    Lead Product(s): Ibuprofen,Pseudoephedrine Hydrochloride

    Therapeutic Area: Neurology Product Name: Ibuprofen/Pseudoephedrine Hydrochloride-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 10, 2023

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    Aurobindo's Generic Lurasidone Hydrochloride Receives Approval in U.S.

    Details:

    Lurasidone hydrochloride is an atypical antipsychotic that is a D2 and 5-HT2A (mixed serotonin and dopamine activity) to improve cognition. It improves negative symptoms of psychoses and reduce the extrapyramidal side effects associated with typical antipsychotics.


    Lead Product(s): Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Lurasidone Hydrochloride-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 10, 2023

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