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Tolterodine tartrate

CAS No.

124937-52-6

Reference product

Detrusitol/PFIZER

Polymorphic form

Crystalline Form I

Therapeutic Area

Genito-urinary system & sex hormones

Status

commercial

EU DMF readiness

CEP

Other documentation

Canadian DMF

Drug description:

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.

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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).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
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.

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