Insulin Glargine Injection 100 IU/mL (rDNA origin)

Insulin Glargine Injection 100 IU/mL (rDNA origin)
Product Description

Long-acting basal insulin analogue providing approximately 24-hour glycaemic control with a flat, peakless pharmacokinetic profile and a correspondingly lower risk of nocturnal hypoglycaemia than NPH insulin. Indicated for type 1 and type 2 diabetes mellitus as once-daily basal therapy. Manufactured by Regenix at its dedicated sterile insulin facility in Chennai, India under WHO-GMP and Schedule M, with drug substance from a qualified insulin 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 Insulin Glargine (rDNA origin) 100 IU.
    • Form: sterile clear solution for subcutaneous injection
    • Onset of action: approximately 1 to 2 hours
    • Profile: no pronounced peak; duration of action up to 24 hours
    • Administration: once daily by subcutaneous injection at the same time each day, rotating sites to avoid lipodystrophy
    • Storage: 2°C to 8°C, do not freeze; protect from light. Validated cold chain per WHO TRS 961 Annex 9 with qualified shippers and real-time data loggers
    • Therapeutic area: diabetes mellitus, type 1 and type 2
  • Selling Points
    Quality Service; Small Orders Accepted;
    • Flat 24-hour basal profile with no pronounced peak
    • WHO-GMP and Schedule M manufacture at a dedicated sterile insulin facility 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
    Long-acting basal insulin analogue
  • 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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