Product

Nifedipine

Pharmaceutical Form

Tablets

Strengths

30 mg and 60 mg

Release Characteristics

Sustained Release (like Bayer’s – UK – ADALAT LA – Gastrointestinal The-rapeutic System GITS)

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Multiple dose two-way crossover bioequiva-lence study on 24 healthy volunteers vs. Bayer’s (UK) ADALAT LA, nifedipine sustained release 60 mg tablets. Single dose two-way crossover bioequivalence study on 24 healthy volunteers vs. Bayer’s (FRANCE) CHRONADALATE LP, nifedipine sus-tained release 30 mg tablets. Single dose three-way crossover food inter-action bioequivalence study on 24 healthy volunteers vs. Bayer’s (UK) ADALAT LA, nifed-ipine sustained release 60 mg tablets.

Registration underway

Austria, China, Finland, Iran, Israel, Norway, Portugal, Spain, Sweden, Taiwan

Marketing

Australia, Belgium, Colombia, Denmark, France, Greece, Italy, New Zealand, Peru, Singapore, South Korea, Republic of South Africa, The Netherlands, United Kingdom, Uruguay, Venezuela.

Notes

Free Sale Certificate available. A patent of the formulation has been filed in the major coun-tries all over the world and already granted in: Australia, Canada, China, Israel, Italy, New Zealand, Rep. of South Africa and USA.