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TWi Pharma gets ANDA approval for Generic Procardia XL tablets in US

Taiwan-based TWi Pharmaceuticals has received approval for the Abbreviated New Drug Application (ANDA) of the generic equivalent to Procardia XL (Nifedipine) Extended Release Tablets, 30 mg, 60 mg and 90 mg, in the US.

The company has started the launch preparation with its US distributor partner and will commence marketing the product as soon as the launch preparation is completed.

According to IMS data as of December 2013, Procardia XL 30mg, 60mg and 90mg, Extended Release Tablets marketed by Pfizer and the generic equivalent pharmaceuticals marketed by other companies, had annual combined sales of about $116m in the US.

TWi is mainly focusing on developing high barrier generic prescription products ranging from oral controlled release dosage form to new drug delivery systems including the use of nanoparticles, transdermal, and polymeric oral delivery systems.

By leveraging the internal research and development capabilities, along with operational flexibility, process development, manufacturing and regulatory expertise, the company is concentrating on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the US.