Liraglutide Injection 6 mg/mL (rDNA origin)

Liraglutide Injection 6 mg/mL (rDNA origin)
Product Description

Once-daily GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus and for chronic weight management. Liraglutide improves glycaemic control through glucose-dependent insulin secretion, suppression of glucagon release and delayed gastric emptying, with a low intrinsic risk of hypoglycaemia. Manufactured by Regenix at its dedicated sterile facility in Chennai, India under WHO-GMP and Schedule M, with drug substance from a qualified API manufacturer and finished product filled in house. Each batch is released against identity by LC-MS, purity by RP-HPLC, potency by cell-based bioassay, sterility (USP <71>) and bacterial endotoxin (USP <85>). Supplied to licensing and distribution partners with a complete CTD/eCTD dossier (Modules 1-5, ICH M4) including ICH Q1A stability data and country-specific Module 1 adaptation.

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Regenix drugs Ltd

  • Country/Region:
    India
  • Founded:
    2006
  • On CPHI since:
    2024
  • Certificates:
    2
  • Employees:
    50 - 99
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
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Categories
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Specifications
  • Details
    Each mL contains Liraglutide (rDNA origin) 6 mg.
    • Form: sterile clear solution for subcutaneous injection
    • Administration: once daily, at any time of day, independent of meals; abdomen, thigh or upper arm
    • Dosing: stepwise dose titration in accordance with approved labelling
    • Storage: 2°C to 8°C before first use, do not freeze; in-use storage per approved labelling. Validated cold chain per WHO TRS 961 Annex 9 with qualified shippers and real-time data loggers
    • Therapeutic areas: type 2 diabetes mellitus; chronic weight management
  • Selling Points
    • Once-daily GLP-1 receptor agonist with dual use in type 2 diabetes and chronic weight management
    • WHO-GMP and Schedule M manufacture in Chennai, India
    • In-house sterile fill-finish
    • Complete CTD/eCTD dossier (Modules 1-5, ICH M4) with ICH Q1A stability data for partner registrations
    • Country-specific Module 1 adaptation
    • Validated 2-8°C cold chain to distributor warehouse
    • Dossier access and samples for qualified partners under CDA
  • Model
    GLP-1 receptor agonist
  • Supplied from
    India
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Sales Markets
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Regenix drugs Ltd

  • Country/Region:
    India
  • Founded:
    2006
  • On CPHI since:
    2024
  • Certificates:
    2
  • Employees:
    50 - 99
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
View company profile

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