Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Toludesvenlafaxine API manufacturer and supplier in India, providing active pharmaceutical ingredients for qualified pharmaceutical manufacturers, formulation companies, research organizations, and bulk procurement requirements.
Toludesvenlafaxine, also known as Ansofaxine, LY03005, and LPM570065, is a novel antidepressant and serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI). It is the 4-methylbenzoate ester of desvenlafaxine and acts as a prodrug that is metabolized to desvenlafaxine. Toludesvenlafaxine has been developed for the treatment of major depressive disorder (MDD).
The free-base active substance has CAS Number 916918-80-4, molecular formula C₂₄H₃₁NO₃, and molecular weight 381.51 g/mol. The FDA Global Substance Registration System identifies Toludesvenlafaxine as the active form under UNII A7CGH459FN.
Toludesvenlafaxine was authorized in China in November 2022 for major depressive disorder under the brand Ruoxinlin.
Toludesvenlafaxine is a centrally acting antidepressant with activity at the serotonin (5-HT), norepinephrine (NE), and dopamine (DA) transporters. Its triple-reuptake mechanism distinguishes it from conventional selective serotonin or serotonin-norepinephrine reuptake inhibitors.
The API is chemically identified as:
4-[2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenyl 4-methylbenzoate
The compound is also known by the development codes LY-03005, LY03005, LPM-570065, and ODVP2.
Toludesvenlafaxine has been developed as an oral antidepressant for major depressive disorder (MDD). It inhibits the reuptake of serotonin, norepinephrine, and dopamine, thereby increasing the availability of these neurotransmitters in the central nervous system.
Clinical development has included Phase II and Phase III studies in adults with major depressive disorder.
Swapnroop supports qualified pharmaceutical companies, formulation manufacturers, research organizations, and procurement teams requiring Toludesvenlafaxine API for pharmaceutical development and manufacturing requirements.
Toludesvenlafaxine is a relatively new active substance and does not have a widely established USP/BP/Ph. Eur. public monograph that provides universal numerical release limits for the CMS parameters listed below. Therefore, product specifications should be established according to the applicable regulatory dossier, validated analytical methods, and customer requirements.
Toludesvenlafaxine API should be packaged in a suitable pharmaceutical-grade, tightly closed container that protects the material from contamination and environmental exposure.
Storage should follow the applicable manufacturer specification and stability data. Research-grade sources recommend controlled storage conditions for the free base.
Depending on the applicable supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Toludesvenlafaxine API for qualified pharmaceutical, formulation, research, and bulk procurement requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |