Product

Nifedipine

Pharmaceutical Form

Tablets

Strengths

30 mg and 60 mg

Release Characteristics

Sustained Release (like Bayer-Hexal – Germany – NIFEHEXAL UNO)

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available

Parmacokinetics

Multiple dose (steady state – 6 days) two-way crossover bioequivalence study vs. Bayer-Hexal (Germany) NIFEHEXAL UNO, nifedipine sustained release 60 mg tablets.

Registration underway

Peru, USA

Marketing

Italy, Republic of South Africa, United Kingdom.

Notes

A patent of the formulation has been filed in the major countries all over the world and already granted in: Australia, Canada, China, Israel, Italy, New Zealand, Rep. South Af-rica and USA.