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    [{"orgOrder":0,"company":"Xiromed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Xiromed LLC Launches Gemmily\u2122, First-to-Market Generic to Taytulla\u00ae","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Xiromed","sponsor":"IntelGenx","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"IntelGenx Receives FDA GDUFA Date for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Xiromed","sponsor":"IntelGenx","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"IntelGenx Announces Receipt of Complete Response Letter from the FDA for Xiromed-Partnered Buprenorphine Buccal Film","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Xiromed","sponsor":"IntelGenx","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"IntelGenx Updates Status of Buprenorphine Buccal Film ANDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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              IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

              Details:

              Belbuca-Generic (buprenorphine) is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe. It has received CRL from FDA for its resubmitted ANDA.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Neurology Product Name: Belbuca-Generic

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: IntelGenx

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 05, 2024

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              Xiromed

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              IntelGenx Announces Receipt of Complete Response Letter from the FDA for Xiromed-Partnered Buprenorphine Buccal Film

              Details:

              Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Neurology Product Name: Belbuca-Generic

              Highest Development Status: Phase III Product Type: Small molecule

              Recipient: IntelGenx

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 27, 2023

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              IntelGenx Receives FDA GDUFA Date for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film

              Details:

              Buprenorphine Buccal Film is a generic version of Belbuca®, an opioid that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Neurology Product Name: Buprenorphine-Generic

              Highest Development Status: Phase III Product Type: Small molecule

              Recipient: IntelGenx

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 25, 2022

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              Xiromed LLC Launches Gemmily™, First-to-Market Generic to Taytulla®

              Details:

              Taytulla® is an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy. Annual market sales for Taytulla® for the twelve month period ending August, 2020 were $157 million, according to IQVIA™.

              Lead Product(s): Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Gemmily

              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

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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