Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vibegron API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.
Vibegron is a synthetic small-molecule beta-3 adrenergic receptor agonist (β3-adrenergic agonist) used as an active pharmaceutical ingredient in pharmaceutical formulations for the treatment of overactive bladder (OAB). Vibegron selectively activates beta-3 adrenergic receptors in the urinary bladder, resulting in relaxation of the detrusor smooth muscle during the bladder storage phase.
Vibegron is identified by CAS No. 1190389-15-1, with molecular formula C26H28N4O3 and molecular weight approximately 444.5 g/mol.
Vibegron is a complex synthetic small-molecule pharmaceutical compound belonging to the class of beta-3 adrenergic receptor agonists. It is designed to selectively activate β3-adrenergic receptors expressed in the urinary bladder.
Activation of these receptors promotes relaxation of the detrusor smooth muscle and increases bladder storage capacity. Vibegron is therefore commercially important as an API for pharmaceutical products intended for the management of overactive bladder symptoms.
The European Medicines Agency has authorised vibegron-containing medicine Obgemsa for the symptomatic treatment of adult patients with overactive bladder syndrome.
PubChem identifies Vibegron with the molecular formula C26H28N4O3, CAS Number 1190389-15-1 and molecular weight of 444.5 g/mol.
Vibegron API is primarily used in pharmaceutical development and manufacturing of medicines intended for the treatment of overactive bladder (OAB).
Key applications include:
Overactive bladder is associated with symptoms such as urinary urgency, increased urinary frequency and urge urinary incontinence. Vibegron acts on beta-3 adrenergic receptors and promotes relaxation of bladder detrusor smooth muscle, supporting the storage phase of the urinary bladder.
The EMA indication for vibegron-containing Obgemsa is the symptomatic treatment of adult patients with overactive bladder syndrome.
Vibegron requires appropriate controls for identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable quality attributes as part of pharmaceutical API quality management.
As a complex synthetic small molecule with multiple stereocentres, appropriate control of chemical purity and stereochemical identity is important during pharmaceutical manufacturing.
For pharmaceutical manufacturing, Vibegron API should be evaluated using validated analytical methods appropriate to the drug substance and the intended regulatory market.
Quality evaluation may include analytical testing for identity, assay, related substances and relevant process-related impurities. Additional controls may be applied for residual solvents, elemental impurities, water content and other critical quality attributes according to the applicable specification.
Acceptance criteria should be based on the applicable controlled API specification, regulatory requirements, validated analytical methods and customer requirements.
Swapnroop Drugs & Pharmaceuticals provides Vibegron API manufacturing and supply support for pharmaceutical companies, formulation developers and qualified customers involved in urological pharmaceutical development and manufacturing.
As a Vibegron API manufacturer and supplier in India, Swapnroop supports requirements involving:
Vibegron API should be stored in suitable tightly closed pharmaceutical-grade containers under controlled environmental conditions.
The material should be protected from excessive moisture, heat, light and unsuitable environmental exposure. Storage conditions should follow the applicable product specification, safety documentation and validated stability requirements.
For commercial pharmaceutical API handling, exact storage conditions should be established according to the manufacturer's stability data, packaging configuration and applicable regulatory documentation.
Typical pharmaceutical documentation may include:
Documentation requirements may vary according to the customer's intended market, regulatory requirements and qualification process.
Quality control for Vibegron API may include analytical evaluation of identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable pharmaceutical quality attributes.
Vibegron contains four defined stereocentres and has a complex molecular structure. Appropriate analytical procedures are therefore important for confirming the identity, purity and consistency of the active pharmaceutical ingredient.
The EMA assessment report classifies Vibegron as a BCS Class III drug substance, based on high solubility and low permeability. This classification is relevant to pharmaceutical development and formulation considerations.
For commercial API manufacturing, analytical testing should be performed using validated methods and controlled specifications applicable to the intended pharmaceutical product and regulatory market.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Vibegron API for formulation, development and regulated pharmaceutical manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Vibegron API Manufacturer and Supplier in India for urological and pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |