Product

Nifedipine

Pharmaceutical Form

Tablets

Strengths

10 mg and 20 mg

Release Characteristics

Sustained Release (like Bayer’s – UK – ADALAT LA tablets)

Posology

Twice daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available

Parmacokinetics

Multiple dose (steady state – 6 days) two-way crossover bioequivalence study vs. Bayer’s (UK) ADALAT LA, nifedipine sustained release 20 mg tablets. Single dose two-way crossover bioequivalence study vs. Bayer’s (UK) ADALAT LA, nifedipine sustained release 10 mg tablets.

Registration underway

Marketing

Croatia, Greece, Portugal, United Kingdom.

Notes

Free Sale Certificate available