Ono Pharma Announces Transfer of the Manufacturing and Marketing Approval Authorization for Opalmon® Tablets and Prostandin® Ointment to Daito Pharmaceutical Co., Ltd.
Osaka, Japan, March 2, 2026 – Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) announced today that it has agreed to transfer the manufacturing and marketing approval authorization (MMAA) for Opalmon®* Tablets 5 μg (generic name: Limaprost Alfadex; "Opalmon Tablets") and Prostandin®* Ointment 0.003% (generic name: Alprostadil Alfadex; "Prostandin Ointment ") which Ono has retained to Daito Pharmaceutical Co., Ltd. (Headquarters: Toyama, Japan; President and CEO: Hiroshi Matsumori; "Daito").
The companies are currently proceeding with the transfer procedures, including the transfer of manufacturing technology, and the MMAA transfer is scheduled to be completed by the end of November 2026.
Daito has long been entrusted with the formulation manufacturing and some of the packaging processes for Opalmon Tablets. Through this agreement, manufacturing sites will be consolidated, and the product will remain available, with the aim of ensuring a highly stable supply throughout the world.
* Opalmon and Prostandin are registered trademarks of Ono, but will be transferred to Daito along with the succession of MMAA.
| Product name | Therapeutic category |
|---|---|
| OPALMON® Tablets 5 μg | Oral prostaglandin E1 derivative formulation |
| PROSTANDIN® OINTMENT 0.003% | Prostaglandin E1 formulation |
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Opalmon Tablets
Product name OPALMON® Tablets 5 μg Generic name Limaprost Alfadex Therapeutic category Oral prostaglandin E1 derivative formulation Content 5 μg Dosage form Uncoated tablet Indication - Improvement of ischemic symptoms such as ulcers, pain, and coldness associated with thromboangiitis obliterans.
- Improvement of walking ability and subjective symptoms (lower limb pain and lower limb numbness) associated with acquired lumbar spinal canal stenosis (patients with normal SLR test results and bilateral intermittent claudication).
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Prostandin Ointment
Product name PROSTANDIN® OINTMENT 0.003% Generic name Alprostadil Alfadex Therapeutic category Prostaglandin E1 formulation Content 30 μg (0.003%) of Alprostadil per gram as Alprostadil Alfadex Dosage form Ointment Indication - Bedsores
- skin ulcers (burn ulcers, diabetic ulcers, leg ulcers, and postoperative ulcers)
Daito Pharmaceutical Co., Ltd.
Daito (Toyama, Japan) is a global pharmaceutical company engaged in activities ranging from research and development to manufacturing, with two core pillars: active pharmaceutical ingredients and formulations. Since its founding in 1942, it has continued to manufacture and sell active pharmaceutical ingredients and formulations for prescription and over-the-counter drugs, and has established business relationships with over 90% of pharmaceutical companies in Japan. Refer to the website (www.daitonet.co.jp) for more information.