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Find Clinical Drug Pipeline Developments & Deals by Alembic Pharmaceuticals Limited

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            Lead Product(s): Testosterone

            Therapeutic Area: Endocrinology 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 March 04, 2021

            Details:

            Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62%, Alembic Pharmaceuticals said in a regulatory filing.

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            Lead Product(s): Testosterone

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: ALEOR Dermaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 04, 2021

            Details:

            Aleor Dermaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Testosterone Gel, 1.62%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie.

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            Lead Product(s): Treprostinil Sodium

            Therapeutic Area: Pulmonary/Respiratory Diseases 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 February 12, 2021

            Details:

            Alembic Global Holding SA has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), Multiple-Dose Vials.

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            Lead Product(s): Midodrine

            Therapeutic Area: Cardiology/Vascular Diseases 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 January 22, 2021

            Details:

            The US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 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.

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            Lead Product(s): Metolazone

            Therapeutic Area: Nephrology 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 03, 2020

            Details:

            The approved ANDA is therapeutically equivalent to the reference listed drug product, Zaroxolyn Tablets 2.5 mg, 5 mg, and 1 O mg, of Lannett Company. Metolazone Tablets are indicated for the treatment of salt and water retention caused by heart failure or kidney disease.

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            Lead Product(s): Palbociclib

            Therapeutic Area: Oncology 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 November 09, 2020

            Details:

            The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), lbrance Capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc. (Pfizer).

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            Lead Product(s): Clobetasol Propionate

            Therapeutic Area: Dermatology 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 May 20, 2020

            Details:

            The approved ANDA is therapeutically equivalent to the reference listed drug product, Clobex Shampoo, of Galderma Laboratories, Clobetasol Propionate Shampoo is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.