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- 2022/12
- TWi’ ANDA for Dicyclomine Hydrochloride Capsule (equivalent to BENTYL ®) has been officially approved by US FDA
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December 29 2022 TWi Pharmaceuticals, Inc. (“TWi”) today announced that its ANDA (“Abbreviated New Drug Application”) for Dicyclomine Hydrochloride Capsule (equivalent to BENTYL ®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.
Dicyclomine Hydrochloride Capsule are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. According to IQVIA data, the total sales of Dicyclomine Hydrochloride Capsule in the US were approximately US $28 million for the 12 months ended October 2022.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier to entry generic prescription products ranging from oral controlled release dosage forms to novel drug delivery systems including the utilization of nanoparticles, ophthalmic, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer unparalleled market opportunities in the United States. For more information on TWi Pharmaceuticals and its fully owned US subsidiary, TWi Pharmaceuticals USA, Inc., please visit
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