Sevelamer Hydrochloride Sevelamer Hydrochloride

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    [{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives US FDA Approval to Market Generic Renagel Tablets","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Launches Generic Medication in US Market","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Pharma Arm Gets USFDA Nod for Sevelamer Hydrochloride Tablets","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Receives First Product Approval in China","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Strides receives USFDA Approval for Sevelamer Carbonate for Oral Suspension","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"}]

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              Strides Pharma Science

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              Strides receives USFDA Approval for Sevelamer Carbonate for Oral Suspension

              Details:

              USFDA approved generic version of Sevelamer Carbonate which is used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.

              Lead Product(s): Sevelamer Hydrochloride

              Therapeutic Area: Nephrology Product Name: Renvela-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 September 09, 2023

              Strides Pharma Science

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              Amneal Pharmaceuticals

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              Amneal Receives First Product Approval in China

              Details:

              Sevelamer carbonate film coated tablet is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

              Lead Product(s): Sevelamer Hydrochloride

              Therapeutic Area: Nephrology Product Name: Renvela-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 September 06, 2023

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              Aurobindo Pharma Limited

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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: Approved Product 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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              Lupin Ltd

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              Lupin Launches Generic Medication in US Market

              Details:

              Lupin has launched Sevelamer Hydrochloride tablets (800 mg), a generic equivalent of Genzyme, Renagel tablets, used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market.

              Lead Product(s): Sevelamer Hydrochloride

              Therapeutic Area: Nephrology Product Name: Sevelamer Hydrochloride-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 March 01, 2022

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              Lupin Ltd

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              Lupin Receives US FDA Approval to Market Generic Renagel Tablets

              Details:

              Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer Hydrochloride Tablets (RLD: Renagel®) had estimated annual sales of USD 80 million in the U.S.

              Lead Product(s): Sevelamer Hydrochloride

              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 June 17, 2021

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              Ardelyx

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              Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis

              Details:

              Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care, showed the data analysis from NORMALIZE Phase 4 Study.

              Lead Product(s): Tenapanor,Sevelamer Hydrochloride

              Therapeutic Area: Nephrology Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Kyowa Kirin

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 15, 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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