Anxo’s Oral Isotretinoin Becomes Taiwan’s First Approved Generic

Anxo’s drug for severe acne, “Ozyn Soft Gelatin Capsules”(Ozyn) has received a marketing approval notice from Taiwan Food and Drug Administration (TFDA). The product is not only the first approved product on Anxo’s biphasic softgel capsule technology platform, but also the first domestic generic oral Isotretinoin softgel capsule.

Ozyn was co-developed through a joint investment between Anxo and Sunny Pharmtech Co., Ltd. (“Sunny Pharmtech”), with Anxo responsible for dosage-form development and serving as the marketing authorization holder, while Sunny Pharmtech handles manufacturing. The Taiwan market will be promoted through specialized dermatology distributors, while Anxo is also actively seeking partners in Southeast Asia to expand into overseas markets.

Ozyn as Taiwan’s first approved generic follows a series of strong results from industry collaborations: last year, Anxo’s licensing partner in China successfully obtained marketing approval for its schizophrenia drug; this year, the pulmonary fibrosis P4 generic drug co-developed with Sunny Pharmtech secured distribution licensing for the Middle East market, alongside marketing approval applications submitted to both TFDA and the U.S. FDA.

Ozyn’s active ingredient is Isotretinoin, indicated for the treatment of severe acne and acne that has not responded to other therapies. Acne is a common skin condition caused by pores becoming blocked with oil, bacteria, or dead skin cells, triggering an inflammatory response that results in symptoms such as blackheads, redness, and pustules.