Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tofogliflozin Hydrate API in India, supporting pharmaceutical formulation, generic drug manufacturing, bulk API procurement and export requirements.
Tofogliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor used as an oral antidiabetic active pharmaceutical ingredient. The marketed pharmaceutical substance is Tofogliflozin Hydrate (monohydrate). PMDA identifies the active ingredient in Deberza and Apleway tablets as Tofogliflozin Hydrate.
Tofogliflozin Hydrate is identified by CAS Number 1201913-82-7, with the molecular formula C₂₂H₂₆O₆·H₂O and molecular weight 404.45 g/mol. The anhydrous form has CAS 903565-83-3 and molecular weight 386.40 g/mol.
Tofogliflozin belongs to the SGLT2 inhibitor class of oral antidiabetic drugs. It inhibits sodium-glucose cotransporter 2 in the renal proximal tubule, reducing renal glucose reabsorption and increasing urinary glucose excretion.
Tofogliflozin Hydrate is described by PMDA as a white powder, very soluble in N,N-dimethylacetamide, methanol and ethanol, and sparingly soluble in water. PMDA also reports that the material is not hygroscopic.
The Japanese regulatory dossier reports a melting point of 71–92°C for Tofogliflozin Hydrate.
| Parameter | Details |
|---|---|
| Product Name | Tofogliflozin Hydrate |
| CAS Number | 1201913-82-7 |
| Alternate CAS | 903565-83-3 — Tofogliflozin Anhydrous |
| Molecular Formula | C₂₂H₂₆O₆·H₂O |
| Molecular Weight | 404.45 g/mol |
| Anhydrous Molecular Weight | 386.40 g/mol |
| Development Code | CSG452 / RO-4998452 |
| Drug Class | SGLT2 Inhibitor |
| Therapeutic Category | Antidiabetic API |
| Target | Sodium-Glucose Cotransporter 2 (SGLT2) |
| Physical Form | White powder |
| Hydrate Form | Monohydrate |
PMDA confirms the hydrate form, formula, molecular weight and physical characteristics. PubChem separately identifies anhydrous Tofogliflozin as C₂₂H₂₆O₆ with molecular weight 386.4 g/mol.
Tofogliflozin selectively inhibits SGLT2, a transporter responsible for glucose reabsorption in the renal proximal tubule. Inhibition decreases renal glucose reabsorption and increases urinary glucose excretion, contributing to reduction of blood glucose levels.
Tofogliflozin Hydrate is used as an active pharmaceutical ingredient in oral antidiabetic formulations for Type 2 diabetes mellitus.
PMDA's approval information identifies Tofogliflozin Hydrate-containing products for the treatment of Type 2 diabetes mellitus. The approved Japanese dosage is based on 20 mg of tofogliflozin once daily for adults.
Tofogliflozin API is therefore relevant for:
Swapnroop Drugs & Pharmaceuticals supplies Tofogliflozin Hydrate API for pharmaceutical companies and formulation manufacturers requiring SGLT2 inhibitor APIs.
As a Tofogliflozin API supplier in India, Swapnroop supports bulk procurement, formulation development, generic pharmaceutical manufacturing and international API supply, subject to agreed specifications and applicable regulatory requirements.
Tofogliflozin Hydrate can be supplied for:
Tofogliflozin Hydrate is a crystalline pharmaceutical substance with a defined hydrate form. PMDA's quality dossier identifies the substance as a white powder with a molecular weight of 404.45 g/mol, and reports a melting range of 71–92°C. Stability data showed no change during the reported long-term and accelerated studies under the stated conditions.
For commercial API release, assay, related substances, water, residue on ignition and other analytical acceptance criteria should follow the applicable manufacturer specification or regulatory dossier. Numerical values from research-grade supplier COAs should not be represented as universal regulatory specifications.
PMDA's development dossier reports storage stability using a polyethylene bag plus aluminum bag configuration, with long-term testing at 25°C/60% RH and accelerated testing at 40°C/75% RH.
The API should be protected from contamination and stored according to the applicable approved specification and stability data.
Documentation for Tofogliflozin API may include:
Tofogliflozin Hydrate is an established SGLT2 inhibitor API used in oral antidiabetic formulations. Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Tofogliflozin API in India for formulation development, bulk procurement, commercial manufacturing and export requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Melting Point | 71–92°C |