Tadalafil Tablets
【CONTENTS】Tadalafil and Tadalafil Tablets(CIALIS)
【SPECIFICATIONS】20mg, 5mg
【INDICATIONS】 Erectile Dysfunction(ED)
【DOSAGE AND ADMINISTRATION】
CIALIS for Use as Needed for Erectile Dysfunction
• The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
CIALIS for Once Daily Use for Erectile Dysfunction
• The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.
【REGISTRY CLASSIFICATION】3.1+6
【INTRODUCTION】
Tadalafil was first developed by Eli Lilly Company as a new generation of oral ED drugs ,which was approved by EMA in November,2002 and was approved by FDA in November, 2003. Tadalafil tablets entered the Chinese market in 2005.
CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Although the action mechanism of Tadalafil is consistent with Sildenafil(Viagra),the former has more advantages:
No side effects of blue fantasy and flushing like Viagra.
Enlarge drug effect time.
Not affected by eating.
No effection to normal working and living.
Less amount of utility.
It is estimated that there are more than 150 million ED patients all over the world.As the global population ages,the number of ED patients will continue to increase.According to estimation ,the number may jump to 300 million in 2025. In 2013,sales of the Cialis passed $200 million , growth rate was 45 percent and growth amount was 68 million.By contrast,in 2013, the growth rate of Viagra’s sales was only 3 percent and the growth amount was only 17 million.In the hospital channel ,since the second quarter of 2013,Cialis has surpassed Viagra and has become the leader of hospital channel ED drugs .In the retail channel,according to the former 27 cities’ data from IBM ,the market shares of Cialis has already reached 33 percent in 2013 and shown a significant rising trend .But in comparison,Viagra has losing its monopoly and its market shares reduced to 61 percent .At this speed it is just around the corner that Cialis goes beyond the old ED drugs.
【INTELLECTUAL PROPERTY】
There is no risk of infringement.
【TRANSFER TARGETS】
Process of active pharmaceutical ingredients
Process of tablets production
Data for declaring
【RESEARCH PROGRESS】
Active pharmaceutical ingredients
Enlarge production has completed. The size of enlarge production is 2Kg each batch and single impurity is less than 0.1%.
Tablets
Enlarge production has completed. The size of enlarge production is 50-100 thousand each batch.
Study of test methods has completed.