Teneligliptin Hydrochloride API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Teneligliptin Hydrochloride API Manufacturer in India

Teneligliptin Hydrochloride API is a salt form of Teneligliptin, a synthetic small-molecule dipeptidyl peptidase-4 (DPP-4) inhibitor used in pharmaceutical formulations for the management of type 2 diabetes mellitus.

Teneligliptin inhibits DPP-4, an enzyme responsible for the degradation of incretin hormones. By inhibiting DPP-4 activity, Teneligliptin helps enhance incretin-mediated glucose-dependent insulin secretion and contributes to improved glycemic control.

PubChem identifies Teneligliptin Hydrochloride with the molecular formula C₂₂H₃₁ClN₆OS and molecular weight 463.0 g/mol. The parent Teneligliptin has CAS 760937-92-6.

Swapnroop provides Teneligliptin Hydrochloride API for pharmaceutical formulation, development, analytical research and manufacturing applications.

Teneligliptin Hydrochloride API Overview

Teneligliptin is a long-acting, orally active DPP-4 inhibitor. Its inhibition of DPP-4 increases the availability of incretin hormones such as GLP-1 and GIP, supporting glucose-dependent insulin secretion.

Teneligliptin is primarily associated with pharmaceutical treatment of type 2 diabetes mellitus.

Chemical and Pharmaceutical Profile

Teneligliptin Hydrochloride is the hydrochloride salt of the active molecule Teneligliptin.

Key Chemical Information

Product Name: Teneligliptin Hydrochloride
CAS Number: Not consistently established in authoritative public databases for the simple hydrochloride form
Molecular Formula: C₂₂H₃₁ClN₆OS
Molecular Weight: 463.0 g/mol
Parent API: Teneligliptin
Parent CAS Number: 760937-92-6
API Type: Small-Molecule API
Therapeutic Category: Antidiabetic
Drug Class: DPP-4 Inhibitor
Pharmaceutical Application: Type 2 Diabetes Mellitus

PubChem specifically records the hydrochloride molecular formula as C₂₂H₃₁ClN₆OS and molecular weight as 463.0 g/mol.

Pharmaceutical Applications

Teneligliptin Hydrochloride is associated with pharmaceutical formulations for:

  • Type 2 diabetes mellitus
  • Oral antidiabetic formulations
  • DPP-4 inhibitor drug development
  • Generic pharmaceutical development
  • Pharmaceutical formulation research
  • Analytical and quality-control studies

Quality and Analytical Testing

Teneligliptin Hydrochloride API should be evaluated using validated analytical procedures appropriate to the exact salt form and manufacturing specification.

Typical quality-control parameters may include:

  • Appearance
  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Individual impurities
  • Total impurities
  • Chiral purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Heavy metals, where applicable
  • Specific rotation, where applicable
  • Melting point, where applicable
  • Solubility

Important: The Indian Pharmacopoeia Commission monograph available publicly is for Teneligliptin Hydrobromide Hydrate, not Teneligliptin Hydrochloride. Therefore, the numerical IPC limits for the hydrobromide hydrate should not be copied onto a Teneligliptin Hydrochloride product page.

Teneligliptin Hydrochloride API Manufacturer in India

Swapnroop provides Teneligliptin Hydrochloride API for pharmaceutical formulation, development and manufacturing requirements.

Our quality-focused approach includes controlled manufacturing, analytical characterization and pharmaceutical documentation designed to support pharmaceutical customers.

Packaging and Storage

Teneligliptin Hydrochloride should be packaged in suitable pharmaceutical-grade, well-closed containers that protect the API from moisture, contamination and environmental exposure.

Storage conditions should follow validated stability data and the applicable product specification.

Documentation

Depending on product grade and customer requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product Specification
  • Analytical Test Methods
  • Technical Data Sheet
  • Batch Documentation
  • Stability Information, where available
  • Regulatory Documentation, where applicable

Why Choose Swapnroop for Teneligliptin Hydrochloride API?

  • Quality-focused API manufacturing
  • Controlled manufacturing processes
  • Analytical testing support
  • Batch-specific documentation
  • Pharmaceutical formulation support
  • Technical documentation
  • Consistent quality approach
  • Pharmaceutical development support
  • Manufacturing support

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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