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              Glenmark Pharmaceuticals

              • Development Update

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              INDIA India

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              2ND EUROPEAN HEALTHTECH CEO FORUM

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              Glenmark Pharma Gets USFDA Nod for Erectile Dysfunction Treatment

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              Lead Product(s): Tadalafil

              Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 31, 2020

              Details:

              Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.

              Alembic Pharmaceuticals Limited

              • Development Update

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              INDIA India

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              2ND EUROPEAN HEALTHTECH CEO FORUM

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              Alembic Pharmaceuticals Announces USFDA Final Approval for Asenapine Sublingual Tablets, 5 mg and 10 mg

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              Lead Product(s): Asenapine Maleate

              Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 11, 2020

              Details:

              The approved ANDA is therapeutically equivalent to the reference listed drug product, Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan. Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.

              Indoco Remedies Limited

              • Development Update

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              INDIA India

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              2ND EUROPEAN HEALTHTECH CEO FORUM

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              Indoco Remedies Gets USFDA Nod for Schizophrenia, Bipolar Disorder Treatment Drug

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              Lead Product(s): Olanzapine

              Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 06, 2020

              Details:

              Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder. The drug may also be used in combination with other medication to treat depression and certain mental conditions.

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