Genito-urinary system & sex hormones
EU DMF readiness
Tolterodine tartrate is a diphenylmethane derivative, acts as an anticholinergic agent.
It is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
It is formulated as film coated tablets for oral route of administration.
Mechanism of action:
Tolterodine is a competitive, specific muscarinic receptor antagonist with a selectivity for the urinary bladder over salivary glands in vivo. One of the tolterodine metabolites (5-hydroxymethyl derivative) exhibits a pharmacological profile similar to that of the parent compound. In extensive metabolizers this metabolite contributes significantly to the therapeutic effect.
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).
The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.