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Lead Product(s): Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology Product Name: Ryaltris
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 22, 2021
Details:
Ryaltris® (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg), is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age.
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Lead Product(s): Prednisone
Therapeutic Area: Immunology 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:
Strides Pharma's Prednisone Tablets USP, 10 mg and 20 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).
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Lead Product(s): Loratadine
Therapeutic Area: Immunology 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 08, 2021
Details:
The USFDA has approved company's abbreviated new drug application (ANDA) for Loratadine tablets USP 10 mg for treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy.
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Lead Product(s): Mycophenolate Mofetil,Ciclosporin,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
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 29, 2020
Details:
Mycophenolate Mofetil Tablets USP, 500 mg, are the generic equivalent of CellCept® Tablets of Roche Palo Alto, indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants and to be used with other immunosuppressants.
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Lead Product(s): Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology Product Name: Ryaltris
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Menarini
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 23, 2020
Details:
Glenmark will be responsible for the continued development and regulatory approval of Ryaltris in these markets. Menarini will be responsible for the scientific information and the commercialization of Ryaltris in those markets, following regulatory approval.
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Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Prograf
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 11, 2020
Details:
Glenmark has been granted final approval by the U.S. FDA for TacrolimusCapsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US.
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Lead Product(s): Sirolimus
Therapeutic Area: Immunology 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 October 19, 2020
Details:
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV.
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Lead Product(s): Prednisone
Therapeutic Area: Immunology 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 September 03, 2020
Details:
Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (USFDA).
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Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Cadalimab
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Details:
Adalimumab is a disease-modifying antirheumatic drug and a monoclonal antibody that works by inactivating tumor necrosis factor-alpha (TNFα) recommended in the treatment of many diseases.
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Lead Product(s): Mycophenolate Mofetil,Ciclosporin,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
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:
Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
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