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    [{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Alembic Pharmaceuticals Limited","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharmaceuticals Announces Its Joint Venture, Aleor Dermaceuticals Receives USFDA Approval for Clobetasol Propionate Shampoo, 0.05%","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives USFA Tentative Approval for Antifungal Medication","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives USFDA Tentative Approval for Testosterone Gel, 1.62% (20.25 mg\/1.25 gm actuation).","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Announces its Joint Venture Aleor Dermaceuticals Receives USFDA Tentative Approval for Efinaconazole Topical Solution, 10%","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Gets USFDA Approval for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units\/gram and 1 mg\/gram","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives US FDA Approval for Metrogel Gel","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Alembic Pharmaceuticals Limited","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharmaceuticals Announces Its Joint Venture Aleor Dermaceuticals Receives USFDA Final Approval for Mupirocin Cream USP, 2%","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Alembic Pharmaceuticals Limited","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharmaceuticals' JV Gets USFDA Final Nod for Anti-Fungal Drug","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives Final USFDA Approval for Cold Sore Drug","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]

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              Aleor Dermaceuticals

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              Aleor Dermaceuticals Receives Final USFDA Approval for Cold Sore Drug

              Details:

              Docosanol is a drug used for topical treatment for recurrent herpes simplex labialis episodes, inhibits fusion between plasma membrane and herpes simplex virus envelope, thereby preventing viral entry into cells and subsequent viral replication.

              Lead Product(s): Docosanol

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

              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 04, 2022

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              Alembic Pharmaceuticals' JV Gets USFDA Final Nod for Anti-Fungal Drug

              Details:

              The approved ANDA is therapeutically equivalent to the reference-listed drug product Nystatin and Triamcinolone Acetonide ointment, of strength 100,000 units/gram, used for the treatment of cutaneous candidiasis.

              Lead Product(s): Nystatin,Triamcinolone Acetonide

              Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Recipient: Alembic Pharmaceuticals Limited

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 08, 2022

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              Alembic Pharmaceuticals Announces Its Joint Venture Aleor Dermaceuticals Receives USFDA Final Approval for Mupirocin Cream USP, 2%

              Details:

              Mupirocin cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible strains of S. aureus and S. pyogenes.

              Lead Product(s): Mupirocin

              Therapeutic Area: Infections and Infectious Diseases Product Name: Mupirocin

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Alembic Pharmaceuticals Limited

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 17, 2021

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              Aleor Dermaceuticals Receives US FDA Approval for Metrogel Gel

              Details:

              Aleor Dermaceuticals has received final approval from the US FDA for its Abbreviated New Drug Application for metronidazole gel USP, 1%. The ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel gel, 1%, of Galderma Laboratories LP.

              Lead Product(s): Metronidazole

              Therapeutic Area: Dermatology Product Name: Metrogel

              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 September 06, 2021

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              Alembic Announces its Joint Venture Aleor Dermaceuticals Receives USFDA Tentative Approval for Efinaconazole Topical Solution, 10%

              Details:

              Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

              Lead Product(s): Efinaconazole

              Therapeutic Area: Infections and Infectious 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 April 08, 2021

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              Aleor Dermaceuticals Gets USFDA Approval for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram

              Details:

              The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.

              Lead Product(s): Nystatin,Triamcinolone Acetonide

              Therapeutic Area: Infections and Infectious 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 April 01, 2021

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              Aleor Dermaceuticals Receives USFDA Tentative Approval for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation).

              Details:

              Testosterone gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and Hypogonadotropic hypogonadism.

              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 November 25, 2020

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              Aleor Dermaceuticals Receives USFA Tentative Approval for Antifungal Medication

              Details:

              Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tavaborole Topical Solution, 5%.

              Lead Product(s): Tavaborole

              Therapeutic Area: Infections and Infectious 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 August 13, 2020

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              Alembic Pharmaceuticals Announces Its Joint Venture, Aleor Dermaceuticals Receives USFDA Approval for Clobetasol Propionate Shampoo, 0.05%

              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.

              Lead Product(s): Clobetasol Propionate

              Therapeutic Area: Dermatology Product Name: Clobetasol Propionate-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Recipient: Alembic Pharmaceuticals Limited

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 20, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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