Product

Venlafaxine

Pharmaceutical Form

Capsules

Strengths

37,5 mg, 75 mg and 150 mg

Release Characteristics

Sustained Release (like Wyeth - UK - EFEXOR 150 mg XL capsules)

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Available, carried out by Farmovs-Parexel (South Africa): Single dose under fasting conditions, Single dose under fed conditions, Multiple dose under fasting conditions on 42 healthy volunteers vs. Wyeth’s (UK) EFEXOR XL 150 mg capsules. Single dose under fasting conditions, single dose under fed conditions, on 32 healthy volunteers vs. Wyeth’s (France) Effexor LP 37,5 mg and 75 mg capsules

Registration underway

Colombia,  Egypt,  New Zealand, Poland, Republic of South Africa, Romania,  The Netherlands, Turkey,  Venezuela

Marketing

Croatia, Greece, Spain, South Korea, United Kingdom 

Notes

A patent of the formulation has been filed in the major countries all over the world.