MRI Contrast Agents (API & FDF)

MRI Contrast Agents (API & FDF)
Product Description

Gadopentetate dimeglumine

  • FDF launch in China, 2025H1  (China FDF approval: H20244422, H20244423, H20244424)
  • US DMF 026647, Taiwan DMF 060348, China DMF YBY67662024
  • Full dossier available
Gadoterate meglumine
  • FDF approval in China, 2024/12 (approval # H20249640, H20249641, H20249642)
  • US DMF 034291, Taiwan DMF 003794, China DMF YBY72132024
  • Full dossier available

Innopharmax Inc

  • Country/Region:
    Taiwan
  • Founded:
    2005
  • On CPHI since:
    2026
  • Employees:
    25 - 49
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)

Innopharmax Inc

  • Country/Region:
    Taiwan
  • Founded:
    2005
  • On CPHI since:
    2026
  • Employees:
    25 - 49
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)

More Products from Innopharmax Inc (7)

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    Product D07001 GemOral

    GemOral, or oral gemcitabine, was developed by INNOPHARMAX with proprietary OralPAS® system.
    • GemOral is the best-in-class, low dose oral metronomic chemotherapy product for cancer patients • GemOral is Low dose, low toxicity, shows no sign of myelosuppression, and no side effect of hematological is...
  • BendaReady, Bendamustine RTD injection

    Product BendaReady, Bendamustine RTD injection

    100 mg/4mL (25 mg/mL) as a ready to dilute solution in a multiple-dose vial

    Bendamustine HCl Injection RTD is an alkylating drug indicated for treatment of patients with: 
    • Chronic lymphocytic leukemia (CLL, Binet stages B & C) • Indolent B-cell non-Hodgkin lymphom...
  • Sapropterin Dihydrochloride (API & FDF)

    Product Sapropterin Dihydrochloride (API & FDF)

    Sapropterin tablet is used as a supplement for those with a rare-genetic disorder called Phenylketonuria (PKU). People with PKU cannot metabolize phenylalanine due to either defective production of phenylalanine hydroxylase (PAH), or cannot produce a co-factor called BH4 to activate the enzyme. It is o...
  • Formulation development of BCS class II, III and IV drugs into oral form using OralPAS®, OralPAS Pro®, and MUCR drug delivery platforms

    Product Formulation development of BCS class II, III and IV drugs into oral form using OralPAS®, OralPAS Pro®, and MUCR drug delivery platforms

    • Self-MicroEmulsifying Drug Delivery System (SMEDDS) technology, can be applied with candidates of BCS class II, III, and IV small molecules that are difficult to absorb in oral form, or applied with peptide/protein (OralPAS Pro®) • The oral form enhances drug absorption through structural or fluidt...
  • INNO-029 Riociguat CR

    Product INNO-029 Riociguat CR

    Reduce the dosing frequency (TID to QD), once-daily controlled release based on proprietary MUCR system
  • INNO-027 Oral Teriparatide

    Product INNO-027 Oral Teriparatide

    505b2 new dosage form product based on OralPAS Pro platform - improved and cost-effective ORAL option compared to current SC treatments

  • N11005 Oral Insulin

    Product N11005 Oral Insulin

    •       First prandial oral insulin product made via OralPAS Pro® platform
    •       Rapid-acting (onset within 15 min) and short duration (2 hr), designed to mimic the physiological response to insulin in the control of postprandial hy...