Genito-urinary system & sex hormones
EU DMF readiness
US DMF readiness
Solifenacin succinate is a urinary antispasmodic agent, belongs to anticholinergic class.
Solifenacin is indicated for the treatment for the relief of symptoms of urinary frequency, urinary urgency, or urge urinary incontinence associated with an overactive bladder.
It is formulated as tablets and film coated tablets and suspension for oral route of administration.
Mechanism of action:
Solifenacin is a competitive muscarinic receptor antagonist. Acetylcholine contracts the detrusor smooth muscle through muscarinic receptors of which the M3 subtype is predominantly involved. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion.
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.